A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients

PHASE2TerminatedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

December 26, 2020

Study Completion Date

January 25, 2023

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Eltrombopag

"Patients will receive EPAG in addition to their background standard treatment with Decitabine/Azacitidine~\- concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c."

DRUG

Placebo

"Patients will receive Placebo in addition to their background standard treatment with Decitabine/Azacitidine~\- concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c."

Trial Locations (15)

Unknown

Uniklinik RWTH Aachen, Aachen

Charite Campus Benjamin Franklin, Berlin

Klinikum Chemnitz GmbH, Chemnitz

Universitätsklinikum Dresden, Dresden

Marienhospital Düsseldorf GmbH, Düsseldorf

Universitätsklinikum Essen, Essen

Universitätsklinikum Halle (Saale), Halle

St. Marien-Hospital Hamm, Hamm

Klinikum rechts der Isar der TU München, München

Klinikum Nürnberg-Nord, Nuremberg

Medizinisches Versorgungszentrum für Blut- und Krebserkrankungen, Potsdam

Wissenschaftskontor Nord GmbH & Co KG, Rostock

Diakonie-Klinikum Schwäbisch Hall gGmbH, Schwäbisch Hall

Rems-Murr-Klinikum Winnenden, Winnenden

Universitätsklinikum Würzburg, Würzburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Technische Universität Dresden

OTHER