NCT04273802 - CPX-351 in Higher Risk Myelodysplastic Syndromes | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 29, 2020

Primary Completion Date

August 27, 2021

Study Completion Date

July 6, 2022

Conditions

Myelodysplastic Syndromes

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."

Trial Locations (16)

13273

Institut Paoli Calmettes - Unité d'hématologie 3, Marseille

25030

CHU de Besançon - Hôpital Jean Minjoz - Service d'hématologie clinique, Besançon

31059

IUCT-oncopole - Fédération Hématologie - Médecine Interne, Toulouse

33604

CHU de Bordeaux - Hôpital de Haut-Lévêque - Service des maladies du sang, Pessac

35033

Hôpital Pontchaillou - Service d'hématologie clinique, Rennes

38043

CHU de Grenoble - Clinique universitaire d'hématologie, Grenoble

42270

Institut de Cancérologie Lucien Neuwirth - Hématologie Clinique - Thérapie Cellulaire, Saint-Priest-en-Jarez

44093

CHU Hôtel Dieu - Service d'Hématologie Clinique, Nantes

49933

CHU d'Angers - Service des maladies du sang, Angers

72037

CH Le Mans - Service d'onco-hématologie, Le Mans

75010

Hôpital Saint Louis - Service Hématologie Séniors, Paris

80054

CHU d'Amiens - Service d'hématologie clinique et thérapie cellulaire, Amiens

86021

CHU de Poitiers - Service d'onco-hématologie et thérapie cellulaire, Poitiers

87042

CHRU de Limoges - Hôpital Dupuytren - Service d'hématologie clinique et thérapie cellulaire, Limoges

95107

Centre hospitalier Victor Dupouy - Service d'Hématologie, Argenteuil

06202

CHU-Hôpital Archet I - Service d'Hématologie Clinique, Nice

All Listed Sponsors

lead

Groupe Francophone des Myelodysplasies

OTHER