Trials / Completed
CompletedNCT04273802
CPX-351 in Higher Risk Myelodysplastic Syndromes
CPX-351 in Higher Risk Myelodysplastic Syndromes: a Phase I/ II Study as First Line or After Hypomethylating-agents Failure
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Groupe Francophone des Myelodysplasies · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Study of the efficacy of CPX-351 treatment in patients with higher risk myelodysplastic syndromes : as first line treatment or after hypomethylating agents failure
Detailed description
A phase I/II study of the efficacy of CPX-351 treatment in patients with higher risk myelodysplastic syndromes : as first line treatment or after hypomethylating agents failure. CPX-351 is an advanced liposomal formulation of daunorubicin and cytarabine encapsulated at a 1:5 ratio. Patients will receive induction treatment with CPX-351. Patients in response (complete response (CR), complete response with incomplete hematologic improvement (CRi), partial response (PR)) after induction will receive monthly courses of consolidation therapy with CPX-351.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CPX-351 in cohort A | Treatment by CPX-351 via intravenous infusion over 90 minutes. Induction treatment with CPX-351 100 Units/m²/D on days 1, 3 and 5. If response after this induction treatment, 4 courses of consolidation therapy with CPX-351 100 Units/m²/D on day 1. If no response after this induction treatment, a second induction course of CPX-351 100 Units/m²/D on days 1 and 3. If response is achieved after this salvage course, 3 courses of consolidation therapy with CPX-351 100 Units/m²/D on day1. |
| DRUG | CPX-351 in cohort B | Treatment by CPX-351 via intravenous infusion over 90 minutes. This will be a dose-finding study : CPX-351 100 Units/m²/D on days 1, 3 and 5 or CPX-351 100 Units/m²/D on days 1 and 3 or CPX-351 60 Units/m²/D on days 1 and 3. In response after induction treatment, 4 monthly courses of consolidation therapy with CPX-351 at the same dose on day 1. |
Timeline
- Start date
- 2020-04-29
- Primary completion
- 2021-08-27
- Completion
- 2022-07-06
- First posted
- 2020-02-18
- Last updated
- 2022-07-07
Locations
16 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04273802. Inclusion in this directory is not an endorsement.