NCT04061239View on ClinicalTrials.gov

Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 19, 2019

Primary Completion Date

March 31, 2026

Study Completion Date

September 30, 2026

Conditions
MDSAML
Interventions
DRUG

CPX-351

CPX-351 is a liposomal formulation with a fixed 5:1 molar ratio of cytarabine and daunorubicin. It will be administered as a 90-minute intravenous infusion.

DRUG

Daunorubicin

Daunorubicin is commercially available as a powder for reconstitution in 20 mg vials. In this trial, daunorubicin should be administered as an IV infusion over 60 min.

DRUG

Cytarabine

Cytarabine is commercially available as vials/bottles for preparation of diluted infusion solution. Cytarabine will be administrated intravenously. In this trial, cytarabine is administered as a continuous infusion.

DRUG

Azacitidine

Azacitidine at 75mg/m² for 7 days. Patients should receive a minimum of 2 and up to 6 cycles.

Trial Locations (28)

4020

RECRUITING

Ordensklinikum Linz Elisabethinen GmbH, Linz

5020

WITHDRAWN

Uniklinikum Salzburg - Landeskrankenhaus, Salzburg

12200

RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

13125

RECRUITING

Helios Klinikum Berlin-Buch GmbH, Berlin

15236

RECRUITING

Klinikum Frankfurt (Oder) GmbH, Frankfurt

18055

RECRUITING

Universitätsmedizin Rostock, Rostock

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

40225

RECRUITING

Universitätsklinikum Düsseldorf, Düsseldorf

45122

RECRUITING

Universitätsklinikum Essen, Essen

48149

RECRUITING

Universitätsklinikum Münster, Münster

50937

RECRUITING

Universitätsklinikum Köln, Cologne

52074

RECRUITING

Universitätsklinikum Aachen, Aachen

53127

RECRUITING

Universitätsklinikum Bonn (UKB), Bonn

56068

RECRUITING

Gemeinschaftsklinikum Mittelrhein gGmbH, Koblenz

60590

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt

68167

RECRUITING

Universitätsmedizin Mannheim, Mannheim

69120

RECRUITING

Universitätsklinikum Heidelberg, Heidelberg

70376

RECRUITING

Robert-Bosch-Krankenhaus Stuttgart, Stuttgart

72076

RECRUITING

Universitätsklinikum Tübingen, Tübingen

81675

RECRUITING

Klinikum rechts der Isar der TU München, München

86156

RECRUITING

Universitätsklinikum Augsburg, Augsburg

89081

RECRUITING

Universitätsklinikum Ulm, Ulm

90419

RECRUITING

Klinikum Nürnberg, Nuremberg

09113

RECRUITING

Klinikum Chemnitz-gGmbH, Chemnitz

01307

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

06120

RECRUITING

Universitätsklinikum Halle, Halle

07740

RECRUITING

Universitätsklinikum Jena, Jena

Unknown

RECRUITING

Universitätsklinikum Leipzig AöR, Leipzig

All Listed Sponsors
lead

GWT-TUD GmbH

OTHER