MedTrace Logo

CPX-351 in Higher Risk Myelodysplastic Syndromes

NCT04273802 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-07

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Pierre PETERLIN, MD · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-29
Primary Completion
2021-08-27
Completion
2022-07-06

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273802 on ClinicalTrials.gov