[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03104491":3,"trial-entities:NCT03104491":319,"trial-summary:NCT03104491":324},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":36,"secondary_outcomes":56,"sex":173,"minimum_age":174,"maximum_age":175,"healthy_volunteers":176,"eligibility_criteria":177,"std_ages":224,"locations":228,"central_contacts":301,"overall_officials":308,"references":310,"see_also_links":318},"NCT03104491","CASE1916","Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia","RECRUITING","2027-05","2026-09","2026-09-10","2017-07-31","Leland Metheny","OTHER",true,"This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects.\n\nThe Phase II portion of this study is to see what side effects are seen with medication after transplant.\n\nInotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed\u002Frefractory acute lymphocytic leukemia (ALL).\n\nInotuzumab ozogamicin is considered experimental in this study.","Study Design This is a Phase I\u002FII study of inotuzumab ozogamicin for the treatment of patients who underwent allogeneic transplantation for ALL and have a high risk of relapse. The Phase I portion of this study will be a 3+3 dose escalation trial. This is followed by a phase 2 cohort at the recommended Phase 2 dose (RP2D). Participants will receive study treatment up to 4 cycles until relapse of disease, unacceptable toxicity, or death, whichever occurs first\n\nPhase I: Inotuzumab Ozogamicin Dosing Escalation Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical\u002Flaboratory assessments) using a continuous monitoring approach.\n\nPhase II: Inotuzumab Ozogamicin Subjects will be assessed for safety and tolerability (including adverse events, serious adverse events, and clinical\u002Flaboratory assessments) using a continuous monitoring approach. In order to be included in the safety profile endpoint review, subjects must have received at least of 1 cycle of treatment.\n\nPrimary Objective\n\nPhase I: To define a post hematopoietic stem cell transplantation maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of inotuzumab ozogamicin.\n\nPhase II: To assess the efficacy of inotuzumab ozogamicin as measured by diseasefree survival (DFS) at one year.\n\nSecondary Objective(s)\n\nPhase I:\n\n* To evaluate disease-free survival (DFS), nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.\n* To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of myeloid toxicity and secondary graft failure and the rate of veno-occlusive disease\u002Fsinusoidal obstruction syndrome (VOD\u002FSOS).\n* To determine if inotuzumab ozogamicin at these doses is effective at eradicating minimal residual disease in this cohort of participants\n\nPhase II:\n\n* To assess additional evidence of efficacy and safety as measured by non-relapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.\n* To determine if inotuzumab ozogamicin at these doses is effective at eradicating MRD.\n* To confirm the safety profile of inotuzumab ozogamicin therapy after transplant including myeloid toxicity, secondary graft failure, and the rate of VOD\u002FSOS.\n* To evaluate the pharmacokinetics of inotuzumab ozogamicin post allogeneic transplant",[18],"Acute Lymphocytic Leukemia",[20,21],"allogeneic hematopoietic stem cell transplantation","donor chimerism","INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},44,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Inotuzumab Ozogamicin","Inotuzumab ozogamicin, IV, 28 day cycles\n\nPhase 1 dosages:\n\nDose Level -2 (0.1 mg\u002Fm\\^2)\n\nDose Level -1 (0.2 mg\u002Fm\\^2)\n\nDose Level 0 (0.3 mg\u002Fm\\^2)\n\nDose Level 1 (0.4 mg\u002Fm\\^2)\n\nDose Level 2 (0.5 mg\u002Fm\\^2)\n\nDose Level 3 (0.6 mg\u002Fm\\^2)",[33],[37,41,44,48,50,52,54],{"measure":38,"description":39,"timeFrame":40},"Phase I MTD","Defined post hematopoietic stem cell transplantation MTD","Up to 112 days (16 weeks)",{"measure":42,"description":43,"timeFrame":40},"Phase I DLTs","Frequency of DLTs during the first two cycles in ALL-participants",{"measure":45,"description":46,"timeFrame":47},"Phase II Median DFS","Efficacy as measured by phase II DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI)\n\nDFS is defined as \"Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR\u002FCRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)\".\n\nDifference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10\n\nIn Phase II, the null hypothesis of H0: DFS at 1-year ≤ 55% versus the alternative hypothesis of Ha: DFS at 1-year ≥ 75% using 1-sided alpha of 10% will be tested","At 3 months after initial treatment",{"measure":45,"description":46,"timeFrame":49},"At 6 months after initial treatment",{"measure":45,"description":46,"timeFrame":51},"At 9 months after initial treatment",{"measure":45,"description":46,"timeFrame":53},"At 1 year after initial treatment",{"measure":45,"description":46,"timeFrame":55},"Post first dose of inotuzumab ozogamicin",[57,60,61,62,63,65,68,69,70,71,73,76,77,78,79,80,83,84,85,86,87,90,91,92,93,94,98,101,104,107,110,113,116,117,120,121,124,125,126,127,128,131,132,133,134,135,137,139,141,143,147,149,151,153,155,157,159,161,164,166,168,169,170,171,172],{"measure":58,"description":59,"timeFrame":47},"Phase I Median DFS","Efficacy as measured by phase I DFS at one year. Estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI)\n\nDFS is defined as \"Time from date of first dose to the date of disease progression (ie,objective progression, relapse from CR\u002FCRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)\"\n\nDifference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10",{"measure":58,"description":59,"timeFrame":49},{"measure":58,"description":59,"timeFrame":51},{"measure":58,"description":59,"timeFrame":53},{"measure":58,"description":59,"timeFrame":64},"Post first dose of inotuzumab ozogamicin on Day 1, Cycle 1, where cycle length is 28 days",{"measure":66,"description":67,"timeFrame":47},"Phase I NRM","Phase I NRM, defined as time from date of first dose to death due to any cause without prior relapse. Criteria used: For ALL, evidence of disease in the blood or bone marrow (flow cytometry or PCR).\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":66,"description":67,"timeFrame":49},{"measure":66,"description":67,"timeFrame":51},{"measure":66,"description":67,"timeFrame":53},{"measure":66,"description":72,"timeFrame":64},"Phase I NRM , defined as time from date of first dose to death due to any cause without prior relapse. Criteria used: For ALL, evidence of disease in the blood or bone marrow (flow cytometry or PCR).\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":74,"description":75,"timeFrame":47},"Phase I Relapse","Phase I relapse rate, defined as time from date of first dose to the date of first relapse.\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":74,"description":75,"timeFrame":49},{"measure":74,"description":75,"timeFrame":51},{"measure":74,"description":75,"timeFrame":53},{"measure":74,"description":75,"timeFrame":64},{"measure":81,"description":82,"timeFrame":47},"Phase I Relapse-related mortality","Phase I Relapse-related mortality, defined time from date of first dose to death due to any cause with prior relapse\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":81,"description":82,"timeFrame":49},{"measure":81,"description":82,"timeFrame":51},{"measure":81,"description":82,"timeFrame":53},{"measure":81,"description":82,"timeFrame":64},{"measure":88,"description":89,"timeFrame":47},"Phase I Median OS","Phase I OS, defined from time from date of first dose to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI\n\nDifference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10",{"measure":88,"description":89,"timeFrame":49},{"measure":88,"description":89,"timeFrame":51},{"measure":88,"description":89,"timeFrame":53},{"measure":88,"description":89,"timeFrame":64},{"measure":95,"description":96,"timeFrame":97},"Phase I Incidence of myeloid toxicity","Number of patients who develop myeloid toxicity while on study, defined as grade of anemia, neutropenia and thrombocytopenia CTCAE 4","At 1 year",{"measure":99,"description":100,"timeFrame":97},"Phase I Incidence of secondary graft failure","Number of patients who develop secondary graft failure while on study, defined as:\n\nEither cytopenias after initial engraftment (ANC \\\u003C500\u002FµL), with (a) donor chimerism of less than 5% or (b) falling donor chimerism with intervention such as second transplant or donor lymphocyte infusion (DLI) or (c) patient death due to cytopenias, and fall in donor chimerism, even if chimerism was \\>5%. Exclusion criteria for diagnosis of GF were (a) disease relapse (b) graft versus host disease or (c) other causes of cytopenias such as, viral infections, or drug induced",{"measure":102,"description":103,"timeFrame":97},"Phase I incidence of veno-occlusive disease\u002Fsinusoidal obstruction syndrome (VOD\u002FSOS)","Safety profile of intervention as measured by incidence of VOD\u002FSOS disease in the phase I portion of the study, defined as the occurrence of 2 of the following 3 clinical criteria:\n\n* Total serum bilirubin level \\>34 μmol\u002FL (\\>2.0 mg\u002FdL).\n* An increase in liver size from baseline or development of right upper quadrant pain of liver origin.\n* Sudden weight gain \\>2.5% during any 72-hour period after infusion of investigational product because of fluid accumulation or development of ascites.",{"measure":105,"description":106,"timeFrame":97},"Phase I rate of VOD\u002FSOS - number of participants affected","Safety profile of intervention as measured by number of participants affected by VOD\u002FSOS disease in the phase I portion of the study, defined as the occurrence of 2 of the following 3 clinical criteria:\n\n* Total serum bilirubin level \\>34 μmol\u002FL (\\>2.0 mg\u002FdL).\n* An increase in liver size from baseline or development of right upper quadrant pain of liver origin.\n* Sudden weight gain \\>2.5% during any 72-hour period after infusion of investigational product because of fluid accumulation or development of ascites.",{"measure":108,"description":109,"timeFrame":97},"Phase I - Percent of participants with grade 3 + AE\u002FSAEs","Phase I safety profile of intervention as measured by percent of participants with grade 3 + AE\u002FSAEs",{"measure":111,"description":112,"timeFrame":47},"Phase II Non-relapse mortality (NRM)","Phase II Non-relapse mortality (NRM), defined as time from date of first dose to death due to any cause without prior relapse.\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":114,"description":115,"timeFrame":49},"Phase II Relapse","Phase II relapse rate, defined as time from date of first dose to the date of first relapse.\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":114,"description":115,"timeFrame":51},{"measure":118,"description":119,"timeFrame":53},"Phase II Relapse-related mortality","Phase II Relapse-related mortality, defined time from date of first dose to death due to any cause with prior relapse\n\nReported as Cumulative Incidence and 2-sided 80% CI and 2-sided 95% CI",{"measure":118,"description":119,"timeFrame":64},{"measure":122,"description":123,"timeFrame":47},"Phase II Median OS","Phase II OS, defined from time from date of first dose to death due to any cause, estimated using Kaplan-Meier, reported as median and 95% CI\n\nDifference in time-to-event endpoints will be tested using a 1-sided log-rank test at a significance level of 0.10",{"measure":122,"description":123,"timeFrame":49},{"measure":122,"description":123,"timeFrame":51},{"measure":122,"description":123,"timeFrame":53},{"measure":122,"description":123,"timeFrame":64},{"measure":129,"description":130,"timeFrame":47},"Phase II Response Rate","Defined as the proportion of patients with a best overall response of eradicating MRD at the time each patient discontinues treatment with Inotuzumab Ozogamicin",{"measure":129,"description":130,"timeFrame":49},{"measure":129,"description":130,"timeFrame":51},{"measure":129,"description":130,"timeFrame":53},{"measure":129,"description":130,"timeFrame":64},{"measure":136,"description":96,"timeFrame":97},"Phase II Incidence of myeloid toxicity",{"measure":138,"description":100,"timeFrame":53},"Phase II Incidence of secondary graft failure",{"measure":140,"description":103,"timeFrame":97},"Phase I incidence of VOD\u002FSOS",{"measure":142,"description":106,"timeFrame":97},"Phase II rate of VOD\u002FSOS - number of participants affected",{"measure":144,"description":145,"timeFrame":146},"Phase II pharmacokinetic (PK) parameters - Cmax","Phase II PK parameter\n\nCmax is maximum concentration. Descriptive statistics (n, mean, SD, %CV, median, minimum, maximum, geometric mean, its associated geometric %CV) of inotuzumab ozogamicin serum concentrations will be presented in tabular form by cycle, day, and nominal time for the PK concentration analysis population.","At Cycle 1 Day 1 (C1D1) after 0 hours (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":148},"At Cycle 1 Day 1 (C1D1) after 1 hour (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":150},"At Cycle 1 Day 1 (C1D1) after 4 hours (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":152},"At Cycle 1 Day 7 (C1D7) (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":154},"At Cycle 2 Day 1 (C2D1) after 0 hours (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":156},"At Cycle 2 Day 1 (C2D1) after 1 hour (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":158},"At Cycle 4 Day 1 (C4D1) after 0 hours (each cycle is 28 days)",{"measure":144,"description":145,"timeFrame":160},"At Cycle 4 Day 1 (C4D1) after 1 hour (each cycle is 28 days)",{"measure":162,"description":163,"timeFrame":146},"Phase II pharmacokinetic (PK) parameters - Ctrough","Phase II PK parameter\n\nCtrough is lowest concertration of Inotuzumab in the blood.Descriptive statistics (n, mean, SD, %CV, median, minimum, maximum, geometric mean, its associated geometric %CV) of inotuzumab ozogamicin serum concentrations will be presented in tabular form by cycle, day, and nominal time for the PK concentration analysis population.",{"measure":162,"description":163,"timeFrame":165},"At Cycle1 Day 1 (C1D1) after 1 hour (each cycle is 28 days)",{"measure":162,"description":163,"timeFrame":167},"At Cycle1 Day 1 (C1D1) after 4 hours (each cycle is 28 days)",{"measure":162,"description":163,"timeFrame":152},{"measure":162,"description":163,"timeFrame":154},{"measure":162,"description":163,"timeFrame":156},{"measure":162,"description":163,"timeFrame":158},{"measure":162,"description":163,"timeFrame":160},"ALL","16 Years","75 Years",false,{"inclusion":178,"exclusion":203,"raw_text":223},[179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,179,180,196,182,183,197,185,186,198,188,189,190,199,200,201,202,193,194,195],"Diagnosis of CD22-positive Acute Lymphoblastic Leukemia","Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia","Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100.","Patients who have\u002Fare either:","Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation","Pre- or Post-Transplant Minimal Residual Disease defined by:","Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.","In second or third complete remission at the time of allogeneic transplantation","Treated with reduced intensity regimens or non-myeloablative conditioning regimens","Lymphoid blast crisis of CML","Are relapsed or refractory to at least 1 line of chemotherapy","Philadelphia-like ALL","Patients who have evidence of donor chimerism after allogeneic transplantation.","ECOG Performance status \\\u003C 2","Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.","Able to adhere to the study visit schedule and other protocol requirements.","Participants must have the ability to understand and the willingness to sign a written informed consent document.","Patients who are between T+40 and T+100 after allogeneic transplantation","Post-Transplant Minimal Residual Disease defined by:","Treated with reduced intensity regimens as defined per institutional standard of practice","Patients who have \\> 80% donor chimerism after allogeneic transplantation.","Philadelphia chromosome positive ALL must have failed at least 1 TKI","ECOG Performance status \\\u003C 1","pre-transplant evaluation, see 10.1.1",[204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222],"Patients with clinical evidence of disease progression prior to enrollment","Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)","Patients with inadequate organ function as defined by:","Creatinine clearance \\\u003C 30ml\u002Fmin","Bilirubin \\> 2X institutional upper limit of normal","AST (SGOT) \\> 2X institutional upper limit of normal","ALT (SGPT) \\> 2X institutional upper limit of normal","GVHD grade III or IV (for patients with a prior allogeneic transplant).","Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)","History of VOD","Use of concomitant TKI or sirolimus","Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)","Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","Pregnant or breastfeeding women are excluded from this study because inotuzumab ozogamicin may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with inotuzumab ozogamicin, breastfeeding should be discontinued if the mother is treated with inotuzumab ozogamicin. These potential risks may also apply to other agents used in this study.","Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)","Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)","Participation in any other investigational drug study or had exposure to any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater)","Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.","Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds","Inclusion Criteria:\n\nPhase 1 Inclusion Criteria\n\n* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia\n* Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia\n* Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100.\n* Patients who have\u002Fare either:\n\n  * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation\n\n    ---Pre- or Post-Transplant Minimal Residual Disease defined by:\n\n    ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.\n  * In second or third complete remission at the time of allogeneic transplantation\n  * Treated with reduced intensity regimens or non-myeloablative conditioning regimens\n  * Lymphoid blast crisis of CML\n  * Are relapsed or refractory to at least 1 line of chemotherapy\n  * Philadelphia-like ALL\n* Patients who have evidence of donor chimerism after allogeneic transplantation.\n* ECOG Performance status \\\u003C 2\n* Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nPhase 2 Inclusion Criteria\n\n* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia\n* Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia\n* Patients who are between T+40 and T+100 after allogeneic transplantation\n* Patients who have\u002Fare either:\n\n  * Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation\n\n    ---Post-Transplant Minimal Residual Disease defined by:\n\n    ----Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.\n  * In second or third complete remission at the time of allogeneic transplantation\n  * Treated with reduced intensity regimens as defined per institutional standard of practice\n  * Lymphoid blast crisis of CML\n  * Are relapsed or refractory to at least 1 line of chemotherapy\n  * Philadelphia-like ALL\n* Patients who have \\> 80% donor chimerism after allogeneic transplantation.\n* Philadelphia chromosome positive ALL must have failed at least 1 TKI\n* ECOG Performance status \\\u003C 1\n* pre-transplant evaluation, see 10.1.1\n* Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nPhase 1 and 2 Exclusion Criteria:\n\n* Patients with clinical evidence of disease progression prior to enrollment\n* Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)\n* Patients with inadequate organ function as defined by:\n\n  * Creatinine clearance \\\u003C 30ml\u002Fmin\n  * Bilirubin \\> 2X institutional upper limit of normal\n  * AST (SGOT) \\> 2X institutional upper limit of normal\n  * ALT (SGPT) \\> 2X institutional upper limit of normal\n* GVHD grade III or IV (for patients with a prior allogeneic transplant).\n* Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)\n* History of VOD\n* Use of concomitant TKI or sirolimus\n* Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because inotuzumab ozogamicin may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with inotuzumab ozogamicin, breastfeeding should be discontinued if the mother is treated with inotuzumab ozogamicin. These potential risks may also apply to other agents used in this study.\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n* Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n* Participation in any other investigational drug study or had exposure to any other investigational agent, device, or procedure, within 21 days (or 5 half-lives, whichever is greater)\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds",[225,226,227],"CHILD","ADULT","OLDER_ADULT",[229,239,252,264,271,286,290],{"facility":230,"status":231,"city":232,"state":233,"zip":234,"country":235,"geoPoint":236},"The University of Kansas Cancer Center","ACTIVE_NOT_RECRUITING","Westwood","Kansas","66205","United States",{"lat":237,"lon":238},39.04056,-94.6169,{"facility":240,"status":7,"city":241,"state":242,"zip":243,"country":235,"contacts":244,"geoPoint":249},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",[245],{"name":246,"role":247,"email":248},"Roman Shapiro, MD","CONTACT","Roman_Shapiro@DFCI.HARVARD.EDU",{"lat":250,"lon":251},42.35843,-71.05977,{"facility":253,"status":7,"city":254,"state":255,"zip":256,"country":235,"contacts":257,"geoPoint":261},"University of Nebraska Medical Center","Omaha","Nebraska","68106",[258],{"name":259,"role":247,"email":260},"Vijaya Bhatt, MD","Vijaya.bhatt@unmc.edu",{"lat":262,"lon":263},41.25626,-95.94043,{"facility":265,"status":231,"city":266,"state":266,"zip":267,"country":235,"geoPoint":268},"Memorial Sloan Kettering Cancer Center","New York","10065",{"lat":269,"lon":270},40.71427,-74.00597,{"facility":272,"status":7,"city":273,"state":274,"zip":275,"country":235,"contacts":276,"geoPoint":283},"University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center","Cleveland","Ohio","44106-5065",[277,281],{"name":278,"role":247,"phone":279,"email":280},"Leland Metheny, MD","800-641-2422","CTUReferral@UHhospitals.org",{"name":12,"role":282},"PRINCIPAL_INVESTIGATOR",{"lat":284,"lon":285},41.4995,-81.69541,{"facility":287,"status":231,"city":273,"state":274,"zip":288,"country":235,"geoPoint":289},"Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center","44195",{"lat":284,"lon":285},{"facility":291,"status":7,"city":292,"state":274,"zip":293,"country":235,"contacts":294,"geoPoint":298},"The James Cancer Hospital and Solove Research Institute","Columbus","43210",[295,297],{"name":296,"role":247},"Jiasheng Wang, MD",{"name":296,"role":282},{"lat":299,"lon":300},39.96118,-82.99879,[302,304],{"name":278,"role":247,"phone":303,"email":280},"1-800-641-2422",{"name":305,"role":247,"phone":306,"email":307},"Ron Sobecks, MD","216-444-6833","sobeckr@ccf.org",[309],{"name":278,"affiliation":272,"role":282},[311,315],{"pmid":312,"type":313,"citation":314},"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":316,"type":313,"citation":317},"38170741","Metheny LL, Sobecks R, Cho C, Fu P, Margevicius S, Wang J, Ciarrone L, Kopp S, Convents RD, Majhail N, Caimi PF, Otegbeye F, Cooper BW, Gallogly M, Malek E, Tomlinson B, Gerds AT, Hamilton B, Giralt S, Perales MA, de Lima M. A multicenter study of posttransplantation low-dose inotuzumab ozogamicin to prevent relapse of acute lymphoblastic leukemia. Blood Adv. 2024 Mar 26;8(6):1384-1391. doi: 10.1182\u002Fbloodadvances.2023011514.",[],{"nct_id":4,"conditions":320,"biomarkers":322},[321],"Acute Lymphoblastic Leukemia",[323],"CD22 Gene",{"nct_id":4,"found":14,"summary":325,"prompt_version":335},{"design":326,"status":327,"heading":328,"summary":329,"follow_up":330,"word_count":331,"commitments":332,"compensation":333,"drugs_mentioned":334},"This is a Phase I\u002FII study with an estimated 44 participants. Phase I will determine the safest dose, followed by Phase II to assess effectiveness.","completed","Inotuzumab Ozogamicin After Transplant for Acute Lymphocytic Leukemia","This study is testing Inotuzumab Ozogamicin in patients with Acute Lymphocytic Leukemia (ALL) who have recently had a stem cell transplant. Inotuzumab Ozogamicin is a combination of an antibody and chemotherapy. The study aims to find a safe dose (Phase I) and then see how well it prevents ALL from coming back (Phase II). You may be able to join if you are between 16 and 75 years old, have CD22-positive ALL, and received an allogeneic (from a donor) stem cell transplant between 40 and 100 days ago. The study will look at how long patients live without their disease returning.","The study will assess disease-free survival at 3 months after initial treatment.",101,"Participants will receive Inotuzumab Ozogamicin intravenously (IV) in 28-day cycles, for up to 4 cycles. Safety and tolerability will be continuously monitored through clinical and laboratory assessments.","Not stated in the trial record.",[33],"v2"]