[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03826992":3,"trial-entities:NCT03826992":154,"trial-summary:NCT03826992":164},{"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":20,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":51,"secondary_outcomes":60,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":113,"locations":116,"central_contacts":138,"overall_officials":141,"references":143,"see_also_links":144},"NCT03826992","V2-MA-1801","Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia","A Phase I Study of Venetoclax Combined With Vyxeos (CPX-351) for Children, Adolescents and Young Adults With Relapsed or Refractory Acute Leukemia","RECRUITING","2028-01","2026-02","2026-02-18","2018-12-27","Children's Hospital Medical Center, Cincinnati","OTHER",true,"This study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.","This is a single-institution Phase I pilot study designed to test the safety and tolerability of combining venetoclax with Vyxeos (CPX-351, cytarabine and daunorubicin liposome) for the treatment of relapsed\u002Frefractory acute leukemia in young patients. Subjects will receive a single course of study therapy consisting of daily, oral or crushed venetoclax at an assigned dose level with a 3-day ramp-up to target dose and Vyxeos administered intravenously at the established dose on Days 1, 3, and 5. In addition to safety and tolerability, the overall response rate to these therapies will be estimated. Pharmacokinetic (PK) analysis will also be conducted to define the drug clearance of venetoclax in this combination.",[19],"Leukemia",[21,22,23,24,25,26,27,28,29,30,31],"relapsed","refractory","Vyxeos","Venetoclax","acute myeloid leukemia","acute myeloid leukemia, childhood","mixed-lineage leukemia (MLL)","AML","CPX-351","Venclexta","Histone-lysine N-methyltransferase 2A (KmT2A)","INTERVENTIONAL","TREATMENT",[35],"PHASE1",{"count":37,"type":38},21,"ESTIMATED",[40,47],{"type":41,"name":23,"description":42,"armGroupLabels":43,"otherNames":45},"DRUG","Vyxeos Dose: daunorubicin 44 mg\u002Fm2 and cytarabine 100 mg\u002Fm2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.",[44],"Venetoclax and Vyxeos combination",[46],"cytarabine and daunorubicin liposome, CPX-351",{"type":41,"name":24,"description":48,"armGroupLabels":49,"otherNames":50},"Venetoclax Dose:\n\n1. Dose Level 0 - weight based daily dosing for 21 days\n2. Dose Level -1 - weight based daily dosing for 14 days\n3. Dose Level -2- weight based daily dosing for 10 days\n4. Dose Level -3- weight based daily dosing for 7 days",[44],[30],[52,56],{"measure":53,"description":54,"timeFrame":55},"Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities)","If 2 or more participants have dose limiting toxicities at a given dose level, the maximum tolerated dose will have been exceeded.","28 days",{"measure":57,"description":58,"timeFrame":59},"Treatment related toxicities","Number of related adverse events","60 days",[61,65],{"measure":62,"description":63,"timeFrame":64},"Disease response","Estimate of overall response rate (ORR) defined as (CR\u002FCRi\u002FCRp).","42 days",{"measure":66,"description":67,"timeFrame":59},"Cancer therapeutics-related cardiac dysfunction (CTRCD) in patients who have previously received anthracyclines","Measured by echocardiogram (ECHO)","ALL","1 Year","39 Years",false,{"inclusion":73,"exclusion":98,"raw_text":112},[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"Ages 1 Year to 39 Years","Diagnosis of one of the following:","Acute myeloid leukemia (AML), any subtype except","Patients with acute promyelocytic leukemia (APML) are NOT eligible","Patients with ML-DS are NOT eligible","Myeloid sarcoma","Acute leukemia of ambiguous lineage (ALAL)","Acute undifferentiated leukemia (AUL)","T\u002Fmyeloid mixed phenotype acute leukemia (MPAL)","B\u002Fmyeloid MPAL","MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible","T-cell acute lymphoblastic leukemia (T ALL)","Early thymocyte precursor (ETP) ALL","KMT2A-rearranged ALL","Disease Status","Relapsed\u002FRefractory AML, MPA, and AUL","Untreated therapy related AML","Relapsed\u002FRefractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL","Karnofsky\u002FLanksy performance level score of greater than or equal to 50 percent.","Prior therapy requirements","Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure","14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine","2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone marrow radiation","Adequate renal, liver, cardiac, and central nervous system (CNS) function",[75,99,100,101,102,103,104,105,106,107,108,109,110,111],"Myeloid Leukemia associated with Down Syndrome (ML-DS)","Acute Promyelocytic Leukemia (APML)","Acute leukemia with CNS status 3 involvement","Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)","Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder","Wilson's Disease or other copper-metabolism disorder","Pregnant or breastfeeding","Uncontrolled infection","Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum","Receipt of growth factors within 7 days prior to enrollment","Currently receiving another investigational drug","Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea)","Unable to comply with the safety monitoring requirements of the study","Inclusion Criteria:\n\n* Ages 1 Year to 39 Years\n* Diagnosis of one of the following:\n\n  * Acute myeloid leukemia (AML), any subtype except\n\n    * Patients with acute promyelocytic leukemia (APML) are NOT eligible\n    * Patients with ML-DS are NOT eligible\n  * Myeloid sarcoma\n  * Acute leukemia of ambiguous lineage (ALAL)\n\n    * Acute undifferentiated leukemia (AUL)\n    * T\u002Fmyeloid mixed phenotype acute leukemia (MPAL)\n    * B\u002Fmyeloid MPAL\n    * MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible\n  * T-cell acute lymphoblastic leukemia (T ALL)\n  * Early thymocyte precursor (ETP) ALL\n  * KMT2A-rearranged ALL\n* Disease Status\n\n  * Relapsed\u002FRefractory AML, MPA, and AUL\n  * Untreated therapy related AML\n  * Relapsed\u002FRefractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL\n* Karnofsky\u002FLanksy performance level score of greater than or equal to 50 percent.\n* Prior therapy requirements\n\n  * Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure\n  * 14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine\n  * 2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone marrow radiation\n* Adequate renal, liver, cardiac, and central nervous system (CNS) function\n\nExclusion Criteria:\n\n* Diagnosis of one of the following:\n\n  * Myeloid Leukemia associated with Down Syndrome (ML-DS)\n  * Acute Promyelocytic Leukemia (APML)\n  * Acute leukemia with CNS status 3 involvement\n  * Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)\n  * Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder\n  * Wilson's Disease or other copper-metabolism disorder\n* Pregnant or breastfeeding\n* Uncontrolled infection\n* Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum\n* Receipt of growth factors within 7 days prior to enrollment\n* Currently receiving another investigational drug\n* Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea)\n* Unable to comply with the safety monitoring requirements of the study",[114,115],"CHILD","ADULT",[117],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":135},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229","United States",[124,129,132],{"name":125,"role":126,"phone":127,"email":128},"Site Public Contact","CONTACT","513-636-2799","cancer@cchmc.org",{"name":130,"role":131},"John Perentesis, MD","PRINCIPAL_INVESTIGATOR",{"name":133,"role":134},"Laura Agresta, MD","SUB_INVESTIGATOR",{"lat":136,"lon":137},39.12711,-84.51439,[139],{"name":140,"role":126,"phone":127,"email":128},"Site Pulblic Contact",[142],{"name":130,"affiliation":13,"role":131},[],[145,148,151],{"label":146,"url":147},"Cincinnati Children's Cancer and Blood Diseases Institute","http:\u002F\u002Fwww.cincinnatichildrens.org\u002Fresearch\u002Fdivisions\u002Fc\u002Fcbdi\u002Fdefault\u002F",{"label":149,"url":150},"Cincinnati Children's Hospital Oncology Division","http:\u002F\u002Fwww.cincinnatichildrens.org\u002Fresearch\u002Fdivisions\u002Fo\u002Foncology\u002Fdefault\u002F",{"label":152,"url":153},"Leukemia and Lymphoma Program","http:\u002F\u002Fwww.cincinnatichildrens.org\u002Fservice\u002Fl\u002Fleukemia-lymphoma\u002Fclinical-trials\u002F",{"nct_id":4,"conditions":155,"biomarkers":162},[156,157,158,159,160,161],"Acute Leukemia of Ambiguous Lineage","Acute Myeloid Leukemia","Early T Precursor Acute Lymphoblastic Leukemia","KMT2A-rearranged Acute Lymphoblastic Leukemia","Myeloid Sarcoma","Pre T-ALL",[163],"KMT2A Gene",{"nct_id":4,"found":15,"summary":165,"prompt_version":173},{"design":166,"status":167,"heading":6,"summary":168,"follow_up":166,"word_count":169,"commitments":170,"compensation":171,"drugs_mentioned":172},"Not specified.","completed","{\n   \"Venetoclax Combined With Vyxeos for Relapsed or Refractory Acute Leukemia\",\n   \"This study is looking at combining two medicines, Venetoclax and Vyxeos (CPX-351), for children and young adults (ages 1 to 39) with acute leukemia that has come back or not responded to previous treatments. The main goal is to see if this combination is safe and how well people tolerate it. Researchers will also look at how many people respond to the treatment. You would receive a single course of study therapy, including daily Venetoclax and Vyxeos given on specific days. The study is currently recruiting about 21 participants.\",\n  \"design\": \"This is a single-institution Phase I pilot study, which means it's an early-stage study testing safety and tolerability in a small group of participants.\",\n  \"commitments\": \"You would receive a single course of study therapy, consisting of daily Venetoclax and Vyxeos given intravenously on Days 1, 3, and 5.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"The study will look at treatment-related toxicities for up to 60 days after treatment.\",\n}",172,"Not specified in the trial record.","Not stated in the trial record.",[23,24],"v2"]