Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Refractory Acute Myeloid Leukemia
- Acute Biphenotypic Leukemia
- Acute Myeloid Leukemia
- Mixed Phenotype Acute Leukemia
- Relapsed Myeloid Neoplasm
- Myeloid Neoplasm
- Refractory Acute Biphenotypic Leukemia
- Refractory Mixed Phenotype Acute Leukemia
- Refractory Myeloid Neoplasm
- Relapsed Acute Biphenotypic Leukemia
- Relapsed Acute Myeloid Leukemia
- Relapsed Mixed Phenotype Acute Leukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OUTLINE: This is a dose-escalation study of venetoclax. Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 (if peripheral white blood cell count is less than 20,000/uL), cladribine on days 1-5, cytarabine on 1-5, and mitoxantrone on days 1-3. Patients also receive...
OUTLINE: This is a dose-escalation study of venetoclax. Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 (if peripheral white blood cell count is less than 20,000/uL), cladribine on days 1-5, cytarabine on 1-5, and mitoxantrone on days 1-3. Patients also receive venetoclax orally (PO) on days 1-14. Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone, and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 12 months.
Tracking Information
- NCT #
- NCT04797767
- Collaborators
- AbbVie
- Investigators
- Principal Investigator: Mary-Beth M. Percival Fred Hutch/University of Washington Cancer Consortium
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