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

Leukemia, Nonlymphoblastic, Acute Clinical Trial

Official title:

AML96 - Risk-Adapted and Randomized Postremission-Therapy for Adult Acute Myeloid Leukemia Patients. A Cooperative AML-Study of the German SHG-Study Group.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180115
• Other study ID #: MK1-191
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 16, 2007
• Start date: February 1996
• Est. completion date: November 2008

Study information

• Verified date: July 2007
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Nonlymphoblastic, Acute

Intervention

Drug:
• Cytarabine Dosage

Locations

Country	Name	City	State
Germany	Medical Department I, University Hospital Carl Gustav Carus	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- rate of complete remission
Primary	- overall survival
Primary	- relapse-free survival
Secondary	- frequencies and grade of treatment side effects
Secondary	- deaths within induction therapy
Secondary	- deaths within postremission therapy
Secondary	- feasibility according to dosages and time-intervals