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

Phase 4

Completed

• Conditions: Leukemia, Nonlymphoblastic, Acute

• Registration Number: NCT00180115
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 1996-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2007-07
• Last Update Submitted: 2007-07-16
• Last Update Posted: 2007-07-17
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- rate of complete remission
- overall survival
- relapse-free survival

Secondary Outcome Measures

Name	Time	Method
- frequencies and grade of treatment side effects
- deaths within induction therapy
- deaths within postremission therapy
- feasibility according to dosages and time-intervals

Trial Locations

Locations (1)

Medical Department I, University Hospital Carl Gustav Carus; 🇩🇪 Dresden, Germany