Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a

PHASE3CompletedINTERVENTIONAL
Enrollment

1,222

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

July 18, 2018

Study Completion Date

July 18, 2018

Conditions
Acute Myeloid Leukaemia
Interventions
DRUG

Cytarabine

Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.

BIOLOGICAL

human stem cells

Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate

Trial Locations (1)

04103

University of Leipzig, Hematology, Leipzig

All Listed Sponsors
lead

University of Leipzig

OTHER

NCT01497002 - Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a | Biotech Hunter | Biotech Hunter