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

Detailed criteria

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

Drug
CPX-351
Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2

Locations (3)

Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia
courtney.brown@georgetown.edu 202-687-0354
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey
OncologyResearchReferral@hmhn.org 551-996-1777
University of Pennsylvania
Philadelphia, Pennsylvania
Fatme.Chaloub@pennmedicine.upenn.edu 215-906-8435

Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation

Summary

Eligibility

Interventions

Locations (3)

Compensation

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Details

Conditions