CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Myelodysplastic Syndrome With Excess Blasts-2
- Myeloid Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo alloHCT. ARM B: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease p...
OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo alloHCT. ARM B: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5. Treatment may repeat for an additional cycle for a total of 2 cycles (on days 1 and 3 only of cycle 2) in the absence of disease progression or unacceptable toxicity. Within 60 days after completion of CPX-351, patients undergo alloHCT. After completion of study enrollment, patients are followed up for up to 5 years.
Tracking Information
- NCT #
- NCT04526288
- Collaborators
- Jazz Pharmaceuticals
- Investigators
- Principal Investigator: Filippo Milano Fred Hutch/University of Washington Cancer Consortium
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