Trials / Recruiting
RecruitingNCT04990102
Phase IB/II of CPX-351 for Relapse Prevention in AML
Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Georgetown University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CPX-351 | Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2 |
Timeline
- Start date
- 2023-05-22
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
- First posted
- 2021-08-04
- Last updated
- 2026-03-23
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04990102. Inclusion in this directory is not an endorsement.