Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
NCT ID: NCT03826992
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2018-12-27
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venetoclax and Vyxeos combination
Venetoclax will be given orally on Days per the assigned dose level. A single course consisting of 3 doses of Vyxeos and 7-21 doses of venetoclax depending on the assigned dose level will be administered to participants in this study. Vyxeos will be administered by central venous catheter over 90 minutes on Day 1, 3, and 5.
Venetoclax is given daily by mouth per assigned dose level.
Vyxeos
Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.
Venetoclax
Venetoclax Dose:
1. Dose Level 0 - weight based daily dosing for 21 days
2. Dose Level -1 - weight based daily dosing for 14 days
3. Dose Level -2- weight based daily dosing for 10 days
4. Dose Level -3- weight based daily dosing for 7 days
Interventions
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Vyxeos
Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.
Venetoclax
Venetoclax Dose:
1. Dose Level 0 - weight based daily dosing for 21 days
2. Dose Level -1 - weight based daily dosing for 14 days
3. Dose Level -2- weight based daily dosing for 10 days
4. Dose Level -3- weight based daily dosing for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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/myeloid mixed phenotype acute leukemia (MPAL)
* B/myeloid 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/Refractory AML, MPA, and AUL
* Untreated therapy related AML
* Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL
* Karnofsky/Lanksy 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
Exclusion Criteria
* 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
1 Year
39 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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John Perentesis, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Cincinnati Children's Cancer and Blood Diseases Institute
Cincinnati Children's Hospital Oncology Division
Leukemia and Lymphoma Program
Other Identifiers
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V2-MA-1801
Identifier Type: -
Identifier Source: org_study_id
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