A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

May 31, 2013

Study Completion Date

June 30, 2013

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Elacytarabine plus idarubicin

"Elacytarabine 1000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.~Idarubicin will be administered IV at a fixed dose of 12 mg/ m2/d IV on d 1-3 q3w.~It is intended that patients receive remission-induction treatment either as two combination courses, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d or one combination course, elacytarabine 1000 mg/m2/d + idarubicin 12 mg/m2/d followed by one course elacytarabine 2000 mg/m2/d single therapy."

Trial Locations (8)

12200

Charite University Hospital Benjamin Franklin, Berlin

13273

Institut Paoli-Calmettes, Marseille

27710

Duke University Medical Center, Durham

31059

CHU Toulouse, Hospital Purpan, Toulouse

69437

CHU Lyon, Hospital Edouard Herriot, Lyon

Unknown

Universitätsklinikum Münster, Münster

Haukeland University Hospital, Bergen

D-89081

Universitätsklinikum Ulm, Ulm

Sponsors

Lead Sponsor

Collaborators (2)

All Listed Sponsors
collaborator

Theradex

INDUSTRY

collaborator

Syneos Health

OTHER

lead

Clavis Pharma

INDUSTRY