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

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Completed
• CT.gov ID: NCT00180115
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 153
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Nonlymphoblastic, Acute	Drug: Cytarabine Dosage	Phase 4

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Feb 1, 1996
• Study Completion Date: Nov 1, 2008

Outcome Measures

Primary Outcome Measures

1. - rate of complete remission []

2. - overall survival []

3. - relapse-free survival []

Secondary Outcome Measures

1. - frequencies and grade of treatment side effects []

2. - deaths within induction therapy []

3. - deaths within postremission therapy []

4. - feasibility according to dosages and time-intervals []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Department I, University Hospital Carl Gustav Carus	Dresden		Germany	01307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

• Principal Investigator: Gerhard Ehninger, MD, University Hospital Carl Gustav Carus Dresden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00180115
• Other Study ID Numbers: MK1-191
• First Posted: Sep 16, 2005
• Last Update Posted: Jul 17, 2007
• Last Verified: Jul 1, 2007

• Keywords provided by , ,: acute myeloid leukemia; cytarabine postremission dosage; risk adapted treatment strategy; allogeneic stem cell transplantation; autologous stem cell transplantation
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Cytarabine

Study Results

No Results Posted as of Jul 17, 2007