drugset / Trial / NCT04990102
Phase IB/II of CPX-351 for Relapse Prevention in AML
Phase 1/2
Recruiting
24 enrolled
Georgetown University
Jazz Pharmaceuticals · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2023-05-22
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 20 mg/m2 | — |
| Subject | Daunorubicin | Small molecule | 8.8 mg/m2 | — |