Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation
Georgetown University
Summary
This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Newly diagnosed patients \> 18 years of age * Patients must be in CR or CRh (complete remission with partial count recovery). * Must have received ANY induction treatment with standard consolidation or hypomethylating agent (HMA) + venetoclax, for up to 6 cycles or no more than 12 cycles of treatment. * Must be able to start therapy within 3 months of last documented CR * De novo or secondary AML/treatment related AML (non-M3) including AML with myelodysplasia-related changes (MRC), histologically confirmed * Patients must be ineligible for allogeneic BMT (for any reason…
Interventions
- DrugCPX-351
Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2
Locations (3)
- Georgetown Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey
- University of PennsylvaniaPhiladelphia, Pennsylvania