Phase IB/II of CPX-351 for Relapse Prevention in AML
Part of paid clinical trials in Washington D.C., District of Columbia.
- Sponsor
- Georgetown University
- Study ID
- NCT04990102
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Acute Myeloid Leukemia (AML) in Remission
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CPX-351 — DRUGDaunorubicin 8.8mg/m2 + cytarabine 20mg/m2
Study Details
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.
Key Dates
- Start date
- May 22, 2023
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: CPX-351Dose Level 1: CPX-351 administered through intravenou infusion on Day 1 and Day 3 of 28 day cycle for 6 cycles or Dose Level -1: CPX-351 administered through intravenous infusion on Day 1 of each 28 day cycle for 6 cycles.
Primary Outcome Measure
Maximum tolerate dose (Phase 1) [ Time Frame: 1 cycle (28 day cycle) ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | Kimberley Doucette, MD (PRINCIPAL_INVESTIGATOR) |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | James McCloskey, MD (PRINCIPAL_INVESTIGATOR) |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Catherine Lai, MD (PRINCIPAL_INVESTIGATOR) |