NCT01497002

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

Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,222 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy

Detailed description

Measuring EFS depending on induction therapy

Conditions

• Acute Myeloid Leukaemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-04-01
• Primary completion: 2018-07-18
• Completion: 2018-07-18
• First posted: 2011-12-22
• Last updated: 2024-01-31

Locations

1 site across 1 country: Germany