Biology and Treatment Strategy of AML in Its Subgroups: Multicenter Randomized Trial by the German Acute Myeloid Leukemia Cooperative Group (AMLCG)
NCT00266136 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3500
Last updated 2012-10-26
Summary
The study in patients with primary and secondary AML and high-risk MDS uses a risk-stratified, randomized design to evaluate the role of high-dose araC in induction, of G-CSF priming, and of autologous stem cell transplantation.
Conditions
Interventions
- DRUG
-
see protocol
- DRUG
-
Thioguanine
see protocol
- DRUG
-
Daunorubicin
see protocol
- DRUG
-
see protocol
- DRUG
-
G-CSF
see protocol
- PROCEDURE
-
Autologous stem cell transplantation
for details see protocol
- PROCEDURE
-
Allogeneic stem cell transplantation
for details see protocol
Sponsors & Collaborators
-
Deutsche Krebshilfe e.V., Bonn (Germany)
collaborator OTHER -
German Federal Ministry of Education and Research
collaborator OTHER_GOV -
University Hospital Muenster
lead OTHER
Principal Investigators
-
Thomas Buechner, MD PhD · University of Muenster, Medical Center, Department of Medicine, Hematology and Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-06-30
- Primary Completion
- 2007-01-31
- Completion
- 2012-10-31
Countries
- Germany
Study Locations
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