AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The AML96 study examines the feasibility of a risk-adapted postremission treatment strategy including related and unrelated allogeneic stem cell transplantation for high risk AML patients and related allogeneic and autologous stem cell transplantation for standard risk AML patients in a multi-center setting. Furthermore it randomizes patients between intermediate-dose Cytarabine vs high-dose Cytarabine within the first postremission-course.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Cytarabine

Criteria

Inclusion Criteria:

• de novo or secondary acute myeloid leukemia of the FAB subtypes M0-M2 and M4-M7

• de novo or secondary myelodysplastic syndrome FAB subtypes RAEB and RAEB-T

• written informed consent

Exclusion Criteria:

• severe comorbidities

• severe uncontrolled complications of the leukemia

• previous therapy of leukemia/MDS

• HIV-Infection

• known relevant allergy against study medication

• pregnancy

• missing written informed consent