German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
NCT00199069 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 720
Last updated 2023-03-17
Summary
The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',
Conditions
- Adult Acute Lymphocytic Leukemia
Interventions
- DRUG
-
Asparaginase
- DRUG
-
Vincristine
- DRUG
-
Daunorubicin, Adriamycin
- DRUG
- DRUG
-
Ifosfamide
- DRUG
- DRUG
-
Mitoxantrone
- DRUG
-
Methotrexate
- DRUG
-
6-Mercaptopurine
- DRUG
-
6-Thioguanine
- DRUG
-
VM26
- DRUG
-
Dexamethasone / Prednisolone
- PROCEDURE
-
CNS Irradiation
- PROCEDURE
-
Mediastinal Irradiation
- PROCEDURE
-
Stem Cell Transplantation
Sponsors & Collaborators
-
Deutsche Krebshilfe e.V., Bonn (Germany)
collaborator OTHER -
Goethe University
lead OTHER
Principal Investigators
-
Dieter Hoelzer, MD, PhD · University of Frankfurt, Medical Department II
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1993-04-30
- Primary Completion
- 1999-01-31
- Completion
- 2001-05-31
Countries
- Germany
Study Locations
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