[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04546399":3,"trial-entities:NCT04546399":2824,"trial-summary:NCT04546399":2828},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":397,"secondary_outcomes":409,"sex":417,"minimum_age":418,"maximum_age":419,"healthy_volunteers":15,"eligibility_criteria":420,"std_ages":475,"locations":478,"central_contacts":2810,"overall_officials":2811,"references":2815,"see_also_links":2823},"NCT04546399","NCI-2020-06813","A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)","A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >\u002F= 1 to \u003C 31 Years Old With First Relapse","RECRUITING","2028-06-30","2026-06","2026-06-12","2020-12-17","National Cancer Institute (NCI)","NIH",false,"This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.","PRIMARY OBJECTIVES:\n\nI. To compare event free survival post reinduction (EFS PR) between blinatumomab vs. blinatumomab\u002Fnivolumab in Group 4 patients aged ≥ 1 to \\\u003C31 years old with first relapse of CD19+ B ALL.\n\nII. To compare EFS PR (EFS post-reinduction) between consolidation with blinatumomab vs. blinatumomab\u002Fnivolumab in Group 3 patients aged \\>= 1 to \\\u003C 31 years old with first relapse of CD19+ B ALL.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the safety and tolerability of blinatumomab\u002Fnivolumab in patients aged \\>= 1 to \\\u003C 31 years old with first relapse of CD19+ B ALL.\n\nEXPLORATORY OBJECTIVES:\n\nI. In Group 4 patients, compare EFS PR between blinatumomab monotherapy and blinatumomab\u002Fnivolumab arms as compared to similar patients treated on the predecessor trial AALL1331.\n\nII. In Group 4 patients, compare toxicity as defined by grade 3 or greater adverse events during the first cycle of blinatumomab or blinatumomab\u002Fnivolumab.\n\nIII. In Group 4 patients, compare MRD negative second remission (Rem-2) rate after the first cycle of immunotherapy between blinatumomab monotherapy and blinatumomab\u002Fnivolumab arms.\n\nIV. In patients with Down syndrome (DS) with first relapse of B-ALL, describe the safety, tolerability and efficacy (as defined by MRD negative second remission, Rem-2) after up to two cycles of blinatumomab\u002Fnivolumab.\n\nV. With each Group, perform subset analyses of EFS and overall survival (OS) based on features including degree of marrow disease at relapse, age, sex, body mass index, cytogenetics, site(s) of relapse, percent peripheral blasts at relapse and absolute lymphocyte count at first relapse.\n\nOUTLINE:\n\nPatients \\>= 18 years old with marrow +\u002F- extramedullary (EM) relapse of any duration after initial diagnosis, or patients \\\u003C 18 years old with marrow +\u002F- EM relapse \\\u003C 24 months after initial diagnosis are assigned to Group 1. Patients \\\u003C 18 years old with marrow +\u002F- EM relapse \\>= 24 months from initial diagnosis, or all isolated extramedullary (IEM) relapses \\>= 1 to \\\u003C 31 years old are assigned to Groups 2-3 re-induction. Patients with DS are assigned to Arm G. NOTE: Patients in Group 1 and DS patients with white blood cells (WBC) \\>= 30,000\u002FuL, CNS 2\u002F3 disease, or testicular disease must first receive 1 of 3 pre-immunotherapy treatments.\n\nStarting with amendment 4C (9\u002F19\u002F2024), patients with DS are assigned to group 3 or 4. Patients \\\u003C 18 years with bone marrow first relapse ≥ 36 months from initial diagnosis with MRD \\\u003C0.1% after VXLD reinduction or with isolated CNS\u002Ftesticular extramedullary relapse occurring ≥ 18 months from initial diagnosis with MRD \\\u003C0.1% after VXLD reinduction are assigned to group 3. Patients who do not meet criteria for group 3 will be assigned to group 4. Patients with Down syndrome ≥ 1 to \\\u003C 31 years of age with first bone marrow relapse of B ALL are assigned to arm G.\n\nPRE-IMMUNOTHERAPY TREATMENT FOR PATIENTS WITH WBC \\>= 30,000\u002FuL (CLOSED TO ACCRUAL 9\u002F19\u002F2024 EXCEPT FOR ARM G) : Patients receive methotrexate (MTX) intrathecally (IT) or cytarabine IT or intrathecal triple therapy (ITT) consisting of MTX, hydrocortisone sodium succinate, and cytarabine IT at the time of diagnostic lumbar puncture (LP) or on day 1 (if intrathecal therapy is given with relapse diagnostic LP \\\u003C 7 days prior to the start of protocol therapy). Patients also receive dexamethasone intravenously (IV) or orally (PO) twice daily (BID) on days 1-5, vincristine sulfate via infusion or IV push over 1 minute on day 1. Patients with DS also receive leucovorin calcium PO or IV every 6 hours (q6h) for 2 doses on day 2 or at 24 and 30 hours after each IT administration. Patients should proceed to the next cycle when CNS 1 and no testicular disease is present, no sooner than Day 8 and no later than Day 15.\n\nPRE-IMMUNOTHERAPY TREATMENT FOR CNS 2\u002F3 DISEASE (CLOSED TO ACCRUAL 9\u002F19\u002F2024 EXCEPT FOR ARM G): Patients receive MTX IT or cytarabine IT twice weekly (Q2W) for 5-7 doses or Intrathecal Triple Therapy (ITT) IT Q2W for 3-4 doses until patient is CNS 1. Patients with DS also receive leucovorin calcium PO or IV q6h for 2 doses at 24 and 30 hours after each IT administration. Patients should proceed to the next cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 24.\n\nPRE-IMMUNOTHERAPY TREATMENT FOR TESTICULAR DISEASE(CLOSED TO ACCRUAL 9\u002F19\u002F2024 EXCEPT FOR ARM G): Patients receive MTX IT, cytarabine IT, or ITT IT on days 1 and 15 (day 1 may be omitted if intrathecal therapy is given with relapse diagnostic LP \\\u003C 7 days prior to the start of protocol therapy). Patients with DS also receive leucovorin calcium PO or IV q6h for 2 doses on days 2 and 16 or at 24 and 30 hours after each IT administration. Males with testicular disease at relapse undergo radiation once daily (QD) for a total of 12 fractions over 12 days. Patients should proceed to the next cycle when CNS 1 and no testicular disease is present, no sooner than Day 15 and no later than Day 22.\n\nGROUP 1 (CLOSED TO ACCRUAL 9\u002F19\u002F2024): Patients are randomized to Arm A or Arm B.\n\nARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1, 15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given \\\u003C 7 days prior to the start of this cycle), and MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2.\n\nARM B: Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2.\n\nGROUPS 2-4 VXLD REINDUCTION: Patients receive vincristine sulfate via infusion or IV push over 1 minute on days 1, 8, 15, and 22, dexamethasone PO or IV on days 1-14, doxorubicin hydrochloride IV over 1-15 minutes on day 1, MTX IT on days 1, 8, and 29 (day 1 IT may be omitted if intrathecal therapy is given with relapse diagnostic LP \\\u003C 7 days prior to the start of this cycle) (days 8 and 29 for CNS 1 patients at relapse only), pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 2 and 16 or calaspargase IV over 1-2 hours on day 2 (for patients ≤ 22 years), cytarabine IT on days 4 and 11 (CNS 2 patients at relapse only), then Q2W until 3 consecutive samples are clear of blasts, and ITT IT on days 8, 15, 22, and 29 (CNS 3 patients at relapse only). Patients with CNS 2 disease at relapse that does not resolve to CNS 1 by day 15 receive maintenance chemoradiation before initiation of maintenance. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nGROUP 2 (CLOSED TO ACCRUAL 9\u002F19\u002F2024): The following patients are randomized to Arm C or Arm D: 1) \\>= 1 to \\\u003C 31 years old, IEM relapse \\\u003C 18 months from diagnosis, regardless of MRD after Re-Induction. 2) \\\u003C 18 years old with marrow relapse \\>= 24 to \\\u003C 36 months from diagnosis regardless of MRD after Re-Induction, 3) \\>= 1 to \\\u003C 31 years old, IEM relapse \\>= 18 months, and MRD \\>= 0.1% after Re-Induction, 4) \\\u003C 18 years old with marrow relapse \\>= 36 months, and MRD \\>= 0.1% after Re-Induction.\n\nARM C: Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1 and 2, and MTX IT on days 1 and 15 of cycles 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal MTX is given \\\u003C 7 days prior to the start of cycle 1 ). Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2.\n\nARM D: Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2.\n\nGROUP 3: Patients are randomized to Arm E or Arm F.\n\nARM E:\n\nIMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15 (day 1 may be omitted from cycle 1 if intrathecal therapy is given \\\u003C 7 days prior to the start of this cycle). Immunotherapy cycles 1-2 alternate with Consolidation cycles 1-2.\n\nCONSOLIDATION: Patients receive dexamethasone PO or IV on days 1-5, methotrexate IV, over 24 hours, on days 8 and 22, methotrexate IT on days 8 and 22 (CNS 1\u002F2 at relapse only) or ITT IT on days 8 and 22 (CNS 3 at relapse only).\n\nINTENSIFICATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, methotrexate IV over 24 hours on days 8 and 22, cytarabine IV, over 3 hours on days 43 and 44, asparaginase erwinia chrysanthemi IM on day 44, methotrexate IT on days 1 and 43 (CNS 1\u002F2 at relapse only) or ITT IT on days 1 and 43 (CNS 3 at relapse only).\n\nIMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28, and MTX IT on days 1 and 15 (CNS 1\u002F2 at relapse only) or ITT IT on days 1 and 15 (CNS 3 at relapse only).\n\nMAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on days 1-84, MTX IT on day 1 (only for patients who did not receive cranial radiation), and MTX PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78 (Omit day 1 for patients receiving day 1 IT MTX). Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE CHEMORADIATION: Prior to the first cycle of maintenance therapy, patients with CNS 3 at relapse or CNS 2 at relapse that did not resolve to CNS 1 by day 15 of VXLD Reinduction receive dexamethasone PO BID on days 1-7 and 15-21, vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and pegaspargase IM or IV over 1-2 hours or calaspargase IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse undergo cranial radiation in the form of 3-dimensional (D)-conformal radiation therapy (CRT) over 5 days per week for a total of 10 treatments.\n\nARM F:\n\nIMMUNOTHERAPY CYCLES 1-2: Patients receive dexamethasone PO or IV on day 1 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11 of cycle 1 and on days 1 of cycles 2 and 3, and MTX IT on days 1 and 15 (CNS 1\u002F2 patients at relapse only)(day 1 may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle) or , ITT IT on day 1 (CNS 3 patients at relapse only) (day 1 may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Immunotherapy cycles 1-2 alternate with Consolidation cycles 1-2.\n\nCONSOLIDATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate IV push over 1 minute or via infusion on day 1, methotrexate IV, over 24 hours, on days 8 and 22, methotrexate IT on days 8 and 22 (CNS 1\u002F2 at relapse only) or ITT IT on days 8 and 22 (CNS 3 at relapse only).\n\nINTENSIFICATION CYCLES 1-2: Patients receive dexamethasone PO on days 1-5, vincristine sulfate IV push over 1 minute or via infusion on day 1, mercaptopurine PO on days 1-42, methotrexate IV over 24 hours on days 8 and 22, cytarabine IV, over 3 hours on days 43 and 44, asparaginase erwinia chrysanthemi IM on day 44, methotrexate IT on days 1 and 43 (CNS 1\u002F2 at relapse only) or ITT IT on days 1 and 43 (CNS 3 at relapse only).\n\nIMMUNOTHERAPY CYCLE 3: Patients receive blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 1 and 15 and MTX IT on days 1 and 15.\n\nMAINTENANCE: Patients receive dexamethasone PO BID on days 1-5, 29-33, and 57-61, vincristine sulfate IV push over 1 minute or via infusion on days 1, 29, and 57, mercaptopurine PO on days 1-84, MTX IT on day 1 (only for patients who did not receive cranial radiation), and MTX PO on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 (Omit for patients receiving day 1 IT MTX). Treatment repeats every 12 weeks for 2 years from the start of Re-Induction therapy in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE CHEMORADIATION: Prior to the first cycle of maintenance therapy, patients with CNS 3 at relapse or CNS 2 at relapse that did not resolve to CNS 1 by day 15 of VXLD Reinduction receive dexamethasone PO BID on days 1-7 and 15-21, vincristine sulfate IV push over 1 minute or via infusion on days 1, 8, and 15, and pegaspargase IM or IV over 1-2 hours or calaspargase IV over 1-2 hours on day 1. Patients with CNS 3 and isolated CNS relapse undergo cranial radiation in the form of 3-dimensional (D)-conformal radiation therapy (CRT) over 5 days per week for a total of 10 treatments.\n\nGROUP 4: Patients are randomized to arm H or arm I.\n\nARM H: Patients receive dexamethasone PO or IV on day 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28 and MTX IT on days 1 of cycle 1 only and days 15 and 36 ( for patients with CNS1\u002F2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Cycles repeat every 36 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM I: Patients receive dexamethasone PO or IV on day 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV, over 30 minutes on day 11 of cycle 1 and day 3 of cycle 2 and MTX IT on days 1 of cycle 1 only and days 15 and 36 ( for patients with CNS 1\u002F2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Cycles repeat every 36 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nARM G (DS PATIENTS): Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11 of cycle 1 and day 3 of cycle 2, and MTX IT (for patients with CNS 1\u002F2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with MRD \\\u003C0.01% at the end of Cycle 1 may stop study treatment at the discretion of the treating physician.\n\nPatients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.\n\nAfter completion of study treatment, patients are followed up every 3 months for 1 year.",[19,20],"Down Syndrome","Recurrent B Acute Lymphoblastic Leukemia",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},461,"ESTIMATED",[30,48,72,89,107,111,118,128,165,235,261,268,308,349,370,384],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"RADIATION","3-Dimensional Conformal Radiation Therapy","Undergo 3D-CRT",[35,36],"Group 3, Arm E (dexamethasone, blinatumomab, MTX)","Group 3, Arm F (dexamethasone, blinatumomab, nivolumab)",[38,39,40,41,42,43,44,45,46,47],"3-dimensional radiation therapy","3D Conformal","3D CONFORMAL RADIATION THERAPY","3D CRT","3D radiotherapy","3D-CRT","Conformal Therapy","Radiation Conformal Therapy","Radiation, 3D Conformal","Three dimensional external beam radiation therapy (procedure)",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","Asparaginase Erwinia chrysanthemi","Given IM",[35,36],[54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"Asparaginase Erwinia chrysanthemi (Recombinant)-rywn","Asparaginase Erwinia chrysanthemi, Recombinant-rywn","Asparaginase Erwinia chrysanthemi-rywn","Crisantaspase","Crisantaspase Biobetter JZP-458","Crisantaspasum","Enrylaze","Erwinase","Erwinaze","JZP 458","JZP-458","JZP458","PF743","RC-P JZP-458","Recombinant Asparaginase erwinia chrysanthemi JZP-458","Recombinant Crisantaspase JZP-458","Recombinant Erwinia asparaginase JZP-458","Rylaze",{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":84},"PROCEDURE","Biospecimen Collection","Undergo blood, urine and cerebrospinal fluid collection",[77,78,79,80,81,35,36,82,83],"Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patients","Group 1, Arm A (dexamethasone, blinatumomab, MTX)","Group 1, Arm B (dexamethasone, blinatumomab, MTX)","Group 2, Arm C (dexamethasone, blinatumomab, MTX)","Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX)","Group 4 Arm I (Dexamethasone, blinatumomab, nivolumab)","Group 4, Arm H (dexamethasone blinatumomab)",[85,86,87,88],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"BIOLOGICAL","Blinatumomab","Given IV",[77,78,79,80,81,35,36,82,83],[95,96,97,98,99,100,101,102,103,104,105,106],"AMG 103","AMG-103","AMG103","Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody","Anti-CD19\u002FAnti-CD3 Recombinant Bispecific Monoclonal Antibody MT103","Blincyto","MEDI 538","MEDI-538","MEDI538","MT 103","MT-103","MT103",{"type":73,"name":108,"description":109,"armGroupLabels":110},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[77,78,79,80,81,35,36,82,83],{"type":73,"name":112,"description":113,"armGroupLabels":114,"otherNames":115},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[77,78,79,80,81,35,36,82,83],[116,117],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":49,"name":119,"description":92,"armGroupLabels":120,"otherNames":121},"Calaspargase Pegol",[35,36,82],[122,123,124,125,126,127],"Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)","Asparlas","Calaspargase Pegol-mknl","EZN-2285","SC-PEG E. Coli L-Asparaginase","Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase",{"type":49,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"Cytarabine","Given IT",[77,78,79,35,36,82,83],[133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164],".beta.-Cytosine arabinoside","1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-.beta.-D-Arabinofuranosylcytosine","1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-Beta-D-arabinofuranosylcytosine","1.beta.-D-Arabinofuranosylcytosine","2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-","2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-","Alexan","Ara-C","ARA-cell","Arabine","Arabinofuranosylcytosine","Arabinosylcytosine","Aracytidine","Aracytin","Aracytine","Beta-Cytosine Arabinoside","CHX-3311","Cytarabinum","Cytarbel","Cytosar","Cytosine Arabinoside","Cytosine-.beta.-arabinoside","Cytosine-beta-arabinoside","Erpalfa","Starasid","Tarabine PFS","U 19920","U-19920","Udicil","WR-28453",{"type":49,"name":166,"description":167,"armGroupLabels":168,"otherNames":169},"Dexamethasone","Given PO or IV",[77,78,79,80,81,35,36,82,83],[170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234],"Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Dxevo","Fluorodelta","Fortecortin","Gammacorten","Hemady","Hexadecadrol","Hexadrol","LenaDex","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex",{"type":49,"name":236,"description":130,"armGroupLabels":237,"otherNames":238},"Hydrocortisone Sodium Succinate",[77,78,79,35,36,82,83],[239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260],"(11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt","A-Hydrocort","Buccalsone","Corlan","Cortisol Sodium Succinate","Cortop","Efcortelan","Emergent-EZ","Flebocortid","Hidroc Clora","Hycorace","Hydro-Adreson","Hydrocort","Hydrocortisone 21-Sodium Succinate","Hydrocortisone Na Succinate","Kinogen","Nordicort","Nositrol","Sinsurrene","Sodium hydrocortisone succinate","Solu-Cortef","Solu-Glyc",{"type":73,"name":262,"description":263,"armGroupLabels":264,"otherNames":265},"Lumbar Puncture","Undergo lumbar puncture",[77,78,79,80,81,35,36,82,83],[266,267],"LP","Spinal Tap",{"type":49,"name":269,"description":270,"armGroupLabels":271,"otherNames":272},"Mercaptopurine","Given PO",[35,36],[273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307],"3H-Purine-6-thiol","6 MP","6 Thiohypoxanthine","6 Thiopurine","6-Mercaptopurine","6-Mercaptopurine Monohydrate","6-MP","6-Purinethiol","6-Thiopurine","6-Thioxopurine","6H-Purine-6-thione, 1,7-dihydro- (9CI)","7-Mercapto-1,3,4,6-tetrazaindene","Alti-Mercaptopurine","Azathiopurine","Bw 57-323H","Flocofil","Ismipur","Leukerin","Leupurin","Mercaleukim","Mercaleukin","Mercaptina","Mercaptopurinum","Mercapurin","Mern","NCI-C04886","Puri-Nethol","Purimethol","Purine, 6-mercapto-","Purine-6-thiol (8CI)","Purine-6-thiol, monohydrate","Purinethiol","Purinethol","U-4748","WR-2785",{"type":49,"name":309,"description":310,"armGroupLabels":311,"otherNames":312},"Methotrexate","Given IT, PO, and IV",[77,78,79,80,81,35,36,82,83],[313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348],"Abitrexate","Alpha-Methopterin","Amethopterin","Brimexate","CL 14377","CL-14377","Emtexate","Emthexat","Emthexate","Farmitrexat","Fauldexato","Folex","Folex PFS","Jylamvo","Lantarel","Ledertrexate","Lumexon","Maxtrex","Medsatrexate","Metex","Methoblastin","Methotrexate LPF","Methotrexate Methylaminopterin","Methotrexatum","Metotrexato","Metrotex","Mexate","Mexate-AQ","MTX","Novatrex","Rheumatrex","Texate","Tremetex","Trexeron","Trixilem","WR-19039",{"type":90,"name":350,"description":92,"armGroupLabels":351,"otherNames":352},"Nivolumab",[77,79,81,36,82],[353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369],"ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo",{"type":49,"name":371,"description":372,"armGroupLabels":373,"otherNames":374},"Pegaspargase","Given IM or IV",[35,36],[375,376,377,378,379,380,381,382,383],"L-Asparaginase with Polyethylene Glycol","Oncaspar","Oncaspar-IV","PEG-Asparaginase","PEG-L-Asparaginase","PEG-L-Asparaginase (Enzon - Kyowa Hakko)","PEGLA","Polyethylene Glycol L-Asparaginase","Polyethylene Glycol-L-Asparaginase",{"type":49,"name":385,"description":386,"armGroupLabels":387,"otherNames":388},"Vincristine Sulfate","Given IV push or via infusion",[35,36],[389,390,391,392,393,394,395,396],"Kyocristine","Leurocristine Sulfate","Leurocristine, sulfate","Oncovin","Vincasar","Vincosid","Vincrex","Vincristine, sulfate",[398,402,406],{"measure":399,"description":400,"timeFrame":401},"Minimal residual disease (MRD) negative second remission (Rem-2) rate with blinatumomab vs with blinatumomab + nivolumab (Group 1)","MRD negative Rem-2 be defined as Rem-2 (i.e., achievement of MRD \\\u003C 1% blasts by flow cytometry and resolution of extramedullary disease (for CNS disease, requires CNS 1) ) and bone marrow with MRD \\\u003C 0.01% by flow cytometry. MRD negative Rem-2 rate between Arm A vs Arm B will be compared using a one-sided Z test of proportions with Type I error of 0.10. Interim analysis will be conducted to monitor for futility. The futility boundaries are based on testing the alternative hypothesis at the 0.067 level.","Up to 2 cycles of therapy (each cycle = 36 days)",{"measure":403,"description":404,"timeFrame":405},"Event-free survival post-reinduction (EFS PR) (Group 3)","Comparison of EFS post reinduction between Arm E versus Arm F will be based on a one-sided two-sample logrank test with Type I error of 0.10, to be conducted 3 years after completion of enrollment of Group 3. Interim analysis will be conducted to monitor for futility. The futility monitoring will be based on testing the alternative hypothesis at the 0.067 level. This alpha level corresponds to that which would cause futility stopping if the one-sided two-sample logrank test shows evidence of a hazard ratio \\> 1.0 when half of the expected events are observed.","From date of randomization to date of treatment failure, relapse, second malignancy (SMN) or death due to any cause, assessed up to 10 years after completion of enrollment.",{"measure":407,"description":408,"timeFrame":405},"EFS PR (Group 4)","Comparison of EFS post reinduction between Arm H versus Arm I will be based on a one-sided two-sample logrank test with Type I error of 0.10, to be conducted 3 years after completion of enrollment of Group 3. Interim analysis will be conducted to monitor for futility. The futility monitoring will be based on testing the alternative hypothesis at the 0.067 level. This alpha level corresponds to that which would cause futility stopping if the one-sided two-sample logrank test shows evidence of a hazard ratio \\> 1.0 when half of the expected events are observed.",[410,414],{"measure":411,"description":412,"timeFrame":413},"Dose-limiting toxicity","Will be assessed using the Common Terminology Criteria for Adverse Events version 5.0.","Up to 1 cycle of therapy (each cycle = 36 days)",{"measure":407,"description":415,"timeFrame":416},"Comparison of EFS post-reinduction between Arm C versus Arm D will be based on a one-sided two-sample logrank test with type I error of 0.15, to be conducted 2 years after completion of enrollment of Group 2. The futility monitoring will be based on testing the alternative hypothesis at the 0.092 level.","From date of randomization to date of treatment failure, relapse, disease progression, SMN or death due to any cause, assessed up to 5 years after completion of enrollment","ALL","1 Year","30 Years",{"inclusion":421,"exclusion":452,"raw_text":474},[422,423,424,425,426,427,424,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451],"Patients must be \\>= 1 and \\\u003C 31 years at time of enrollment","Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:","Isolated bone marrow relapse","Isolated central nervous system (CNS) (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse","Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testes","Patients with Down syndrome (DS) are eligible in the following categories:","Combined bone marrow with CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse","Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age","Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay","Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study","Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression","Patients must not have had a prior hematopoietic stem cell transplant","A single intrathecal chemotherapy at the time of relapse will be allowed. If \\\u003C 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted","In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and\u002For hydroxyurea only) is permissible","Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \\>= 30,000\u002Ful at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no \"washout\" is required","Patients with Down syndrome who received pre-enrollment therapy and have a WBC \\\u003C 30,000\u002Ful at the time of enrollment must be given a 24 hour \"washout\" before starting immunotherapy","Note: There is no waiting period or \"washout\" for patients who relapse while receiving upfront therapy","Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR a serum creatinine based on age\u002Fsex as follows (within 7 calendar days prior to enrollment):","Age: Maximum serum creatinine (mg\u002FdL)","1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)","2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)","6 to \\\u003C 10 years: 1 (male), 1 (female)","10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)","13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)","\\>= 16 years: 1.7 (male), 1.4 (female)","The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)","Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram","No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination","All patients and\u002For their parents or legal guardians must sign a written informed consent","All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",[453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473],"Patients with B-lymphoblastic lymphoma (B-LLy)","Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia","Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)","Patients with mixed phenotype acute leukemia (MPAL)","Patients with known Charcot-Marie-Tooth disease","Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype","Patients with active, uncontrolled infection defined as:","Positive bacterial blood culture within 48 hours of study enrollment","Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.","Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \\> 48 hours","A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection","Active viral or protozoal infection requiring IV treatment","Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.","Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible","Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement","Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved","Patients with an active known\u002Fsuspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll","Patients with DS patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are not eligible","Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease","Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab","Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose","Inclusion Criteria:\n\n* Patients must be \\>= 1 and \\\u003C 31 years at time of enrollment\n* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:\n\n  * Isolated bone marrow relapse\n  * Isolated central nervous system (CNS) (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n  * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testes\n* Patients with Down syndrome (DS) are eligible in the following categories:\n\n  * Isolated bone marrow relapse\n  * Combined bone marrow with CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n\n  * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression\n  * Patients must not have had a prior hematopoietic stem cell transplant\n  * A single intrathecal chemotherapy at the time of relapse will be allowed. If \\\u003C 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted\n  * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and\u002For hydroxyurea only) is permissible\n\n    * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \\>= 30,000\u002Ful at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no \"washout\" is required\n    * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \\\u003C 30,000\u002Ful at the time of enrollment must be given a 24 hour \"washout\" before starting immunotherapy\n  * Note: There is no waiting period or \"washout\" for patients who relapse while receiving upfront therapy\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR a serum creatinine based on age\u002Fsex as follows (within 7 calendar days prior to enrollment):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n\n    * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n    * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n    * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n    * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n    * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n    * \\>= 16 years: 1.7 (male), 1.4 (female)\n\n      * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with B-lymphoblastic lymphoma (B-LLy)\n* Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)\n* Patients with mixed phenotype acute leukemia (MPAL)\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype\n* Patients with active, uncontrolled infection defined as:\n\n  * Positive bacterial blood culture within 48 hours of study enrollment\n  * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.\n  * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \\> 48 hours\n  * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\n  * Active viral or protozoal infection requiring IV treatment\n* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.\n* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* Patients with an active known\u002Fsuspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Patients with DS patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are not eligible\n\n  * Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab\n* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose",[476,477],"CHILD","ADULT",[479,497,509,518,526,538,550,562,575,589,596,603,614,622,632,644,656,668,671,681,690,703,716,729,742,754,763,773,782,795,802,816,829,842,856,870,884,897,910,920,933,943,950,962,965,978,991,1001,1013,1027,1040,1053,1067,1080,1089,1099,1111,1124,1137,1151,1163,1176,1189,1202,1206,1219,1232,1245,1255,1262,1270,1283,1290,1297,1308,1315,1322,1331,1334,1344,1347,1351,1358,1365,1371,1378,1390,1393,1400,1403,1410,1417,1424,1438,1447,1460,1474,1486,1496,1505,1518,1527,1535,1542,1545,1548,1552,1559,1563,1567,1571,1574,1577,1587,1591,1594,1600,1604,1608,1612,1616,1623,1633,1637,1641,1655,1668,1680,1692,1699,1712,1725,1738,1750,1763,1770,1781,1791,1800,1808,1815,1827,1839,1852,1866,1879,1891,1903,1916,1928,1942,1955,1968,1980,1984,1997,2009,2016,2029,2043,2055,2068,2078,2092,2105,2117,2130,2139,2152,2165,2179,2189,2196,2210,2223,2235,2244,2258,2271,2283,2293,2306,2319,2326,2335,2348,2357,2370,2380,2389,2402,2416,2430,2443,2456,2464,2471,2483,2496,2509,2519,2526,2534,2546,2553,2566,2573,2587,2600,2613,2619,2626,2638,2651,2663,2678,2691,2705,2719,2733,2747,2761,2771,2784,2797],{"facility":480,"status":8,"city":481,"state":482,"zip":483,"country":484,"contacts":485,"geoPoint":494},"Children's Hospital of Alabama","Birmingham","Alabama","35233","United States",[486,491],{"name":487,"role":488,"phone":489,"email":490},"Site Public Contact","CONTACT","205-638-9285","oncologyresearch@peds.uab.edu",{"name":492,"role":493},"Matthew A. Kutny","PRINCIPAL_INVESTIGATOR",{"lat":495,"lon":496},33.52066,-86.80249,{"facility":498,"status":8,"city":499,"state":482,"zip":500,"country":484,"contacts":501,"geoPoint":506},"USA Health Strada Patient Care Center","Mobile","36604",[502,504],{"name":487,"role":488,"phone":503},"800-388-8721",{"name":505,"role":493},"Hamayun Imran",{"lat":507,"lon":508},30.69436,-88.04305,{"facility":510,"status":511,"city":512,"state":513,"zip":514,"country":484,"geoPoint":515},"Providence Alaska Medical Center","SUSPENDED","Anchorage","Alaska","99508",{"lat":516,"lon":517},61.21806,-149.90028,{"facility":519,"status":511,"city":520,"state":521,"zip":522,"country":484,"geoPoint":523},"Kingman Regional Medical Center","Kingman","Arizona","86401",{"lat":524,"lon":525},35.18944,-114.05301,{"facility":527,"status":8,"city":528,"state":521,"zip":529,"country":484,"contacts":530,"geoPoint":535},"Banner Children's at Desert","Mesa","85202",[531,533],{"name":487,"role":488,"phone":532},"480-412-3100",{"name":534,"role":493},"Joseph C. 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Forouhar",{"lat":2507,"lon":2508},{"facility":2520,"status":511,"city":2521,"state":2459,"zip":2522,"country":484,"geoPoint":2523},"North Star Lodge Cancer Center at Yakima Valley Memorial Hospital","Yakima","98902",{"lat":2524,"lon":2525},46.60207,-120.5059,{"facility":2527,"status":511,"city":2528,"state":2529,"zip":2530,"country":484,"geoPoint":2531},"United Hospital Center","Bridgeport","West Virginia","26330",{"lat":2532,"lon":2533},39.28648,-80.2562,{"facility":2535,"status":8,"city":2536,"state":2529,"zip":2537,"country":484,"contacts":2538,"geoPoint":2543},"West Virginia University Charleston Division","Charleston","25304",[2539,2541],{"name":487,"role":488,"phone":2540},"304-388-9944",{"name":2542,"role":493},"Mohamad H. 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Meyer",{"lat":2564,"lon":2565},39.62953,-79.9559,{"facility":2567,"status":511,"city":2568,"state":2529,"zip":2569,"country":484,"geoPoint":2570},"Camden Clark Medical Center","Parkersburg","26101",{"lat":2571,"lon":2572},39.26674,-81.56151,{"facility":2574,"status":8,"city":2575,"state":2576,"zip":2577,"country":484,"contacts":2578,"geoPoint":2584},"Saint Vincent Hospital Cancer Center Green Bay","Green Bay","Wisconsin","54301",[2579,2582],{"name":487,"role":488,"phone":2580,"email":2581},"920-433-8889","WI_research_admin@hshs.org",{"name":2583,"role":493},"Catherine A. Long",{"lat":2585,"lon":2586},44.51916,-88.01983,{"facility":2588,"status":8,"city":2589,"state":2576,"zip":2590,"country":484,"contacts":2591,"geoPoint":2597},"University of Wisconsin Carbone Cancer Center - University Hospital","Madison","53792",[2592,2595],{"name":487,"role":488,"phone":2593,"email":2594},"800-622-8922","clinicaltrials@cancer.wisc.edu",{"name":2596,"role":493},"Cathy A. 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Lewis",{"lat":2676,"lon":2677},51.05011,-114.08529,{"facility":2679,"status":8,"city":2680,"state":2666,"zip":2681,"country":2668,"contacts":2682,"geoPoint":2688},"University of Alberta Hospital","Edmonton","T6G 2B7",[2683,2686],{"name":487,"role":488,"phone":2684,"email":2685},"780-407-8798","pedsoncologyresearch@ahs.ca",{"name":2687,"role":493},"Sarah J. McKillop",{"lat":2689,"lon":2690},53.55014,-113.46871,{"facility":2692,"status":8,"city":2693,"state":2694,"zip":2695,"country":2668,"contacts":2696,"geoPoint":2702},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",[2697,2700],{"name":487,"role":488,"phone":2698,"phoneExt":2699},"604-875-2345","6477",{"name":2701,"role":493},"Rebecca J. Deyell",{"lat":2703,"lon":2704},49.24966,-123.11934,{"facility":2706,"status":8,"city":2707,"state":2708,"zip":2709,"country":2668,"contacts":2710,"geoPoint":2716},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",[2711,2714],{"name":487,"role":488,"phone":2712,"email":2713},"866-561-1026","ctu_web@cancercare.mb.ca",{"name":2715,"role":493},"Stephanie M. Villeneuve",{"lat":2717,"lon":2718},49.8844,-97.14704,{"facility":2720,"status":8,"city":2721,"state":2722,"zip":2723,"country":2668,"contacts":2724,"geoPoint":2730},"Janeway Child Health Centre","St. John's","Newfoundland and Labrador","A1B 3V6",[2725,2728],{"name":487,"role":488,"phone":2726,"email":2727},"709-777-8727","beverlyj.mitchell@easternhealth.ca",{"name":2729,"role":493},"Lisa A. Goodyear",{"lat":2731,"lon":2732},47.56494,-52.70931,{"facility":2734,"status":8,"city":2735,"state":2736,"zip":2737,"country":2668,"contacts":2738,"geoPoint":2744},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",[2739,2742],{"name":487,"role":488,"phone":2740,"email":2741},"902-470-8520","Research@iwk.nshealth.ca",{"name":2743,"role":493},"Chelsea Ash",{"lat":2745,"lon":2746},44.64269,-63.57688,{"facility":2748,"status":8,"city":2749,"state":2750,"zip":2751,"country":2668,"contacts":2752,"geoPoint":2758},"The Montreal Children's Hospital of the MUHC","Montreal","Quebec","H3H 1P3",[2753,2756],{"name":487,"role":488,"phone":2754,"email":2755},"514-412-4445","info@thechildren.com",{"name":2757,"role":493},"Stephanie Mourad",{"lat":2759,"lon":2760},45.50884,-73.58781,{"facility":2762,"status":8,"city":2749,"state":2750,"zip":2763,"country":2668,"contacts":2764,"geoPoint":2770},"Centre Hospitalier Universitaire Sainte-Justine","H3T 1C5",[2765,2768],{"name":487,"role":488,"phone":2766,"email":2767},"514-345-4931","yvan.samson@umontreal.ca",{"name":2769,"role":493},"Monia Marzouki",{"lat":2759,"lon":2760},{"facility":2772,"status":8,"city":2773,"state":2750,"zip":2774,"country":2668,"contacts":2775,"geoPoint":2781},"Centre Hospitalier Universitaire de Sherbrooke-Fleurimont","Sherbrooke","J1H 5N4",[2776,2779],{"name":487,"role":488,"phone":2777,"email":2778},"819-820-6480","crcinformation.chus@ssss.gouv.qc.ca",{"name":2780,"role":493},"Josee Brossard",{"lat":2782,"lon":2783},45.40008,-71.89908,{"facility":2785,"status":8,"city":2786,"zip":2787,"country":2668,"contacts":2788,"geoPoint":2794},"CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)","Québec","G1V 4G2",[2789,2792],{"name":487,"role":488,"phone":2790,"email":2791},"418-525-4444","rechclinique@crchudequebec.ulaval.ca",{"name":2793,"role":493},"Bruno Michon",{"lat":2795,"lon":2796},46.81228,-71.21454,{"facility":2798,"status":8,"city":2799,"zip":2800,"country":2801,"contacts":2802,"geoPoint":2807},"University Pediatric Hospital","San Juan","00926","Puerto Rico",[2803,2805],{"name":487,"role":488,"phone":2804},"787-474-0333",{"name":2806,"role":493},"Maria E. Echevarria",{"lat":2808,"lon":2809},18.46633,-66.10572,[],[2812],{"name":2813,"affiliation":2814,"role":493},"Stacy L Cooper","Children's Oncology Group",[2816,2820],{"pmid":2817,"type":2818,"citation":2819},"41671463","DERIVED","Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004\u002Fjnccn.2025.7067.",{"pmid":2821,"type":2818,"citation":2822},"35622074","Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080\u002F16078454.2022.2074704.",[],{"nct_id":4,"conditions":2825,"biomarkers":2827},[2826,19],"B Acute Lymphoblastic Leukemia",[],{"nct_id":4,"found":2829,"summary":2830,"prompt_version":2840},true,{"design":2831,"status":2832,"heading":2833,"summary":2834,"follow_up":2835,"word_count":2836,"commitments":2837,"compensation":2838,"drugs_mentioned":2839},"This is an interventional study comparing blinatumomab alone to blinatumomab with nivolumab, with a planned enrollment of 461 participants.","completed","Study of Blinatumomab With or Without Nivolumab for Relapsed B-ALL","This study is for patients aged 1 to 30 years old with B-cell acute lymphoblastic leukemia (B-ALL) that has returned (relapsed). This includes patients with Down Syndrome. It compares two treatments: blinatumomab alone versus blinatumomab combined with nivolumab. Blinatumomab is an antibody that targets and helps kill cancer cells. Nivolumab is a medicine that may boost your immune system. The main goal is to see if adding nivolumab improves how long patients live without the cancer returning (event-free survival). The study plans to enroll 461 participants.","Participants will be followed for event-free survival for up to 10 years after completing enrollment.",86,"You would undergo procedures like blood, urine, and cerebrospinal fluid collection, and bone marrow aspiration. You may also receive 3-Dimensional Conformal Radiation Therapy and Asparaginase Erwinia chrysanthemi.","Not stated in the trial record.",[91],"v2"]