Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR
NCT01246752 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2021-10-29
Summary
Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy
Conditions
- Leukemia, Myeloid, Acute
Interventions
- BIOLOGICAL
-
Human Stem Cell Transplantation
Human allogenic stem cells
- DRUG
-
Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5
Sponsors & Collaborators
-
German Research Foundation
collaborator OTHER -
University Hospital Carl Gustav Carus
lead OTHER
Principal Investigators
-
Martin Bornhaeuser, Prof. (MD) · Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-02-10
- Primary Completion
- 2020-04-30
- Completion
- 2020-04-30
Countries
- Germany
Study Locations
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