German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
Phase 4
15 Years
65 Years
15 Years
65 Years
Open (Enrolling)
Both
Adult Acute Lymphocytic Leukemia
Both
Adult Acute Lymphocytic Leukemia
Trial Information
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003)
Inclusion Criteria:
- Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, thymic T, mature T)
- Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
- Written informed consent
Exclusion Criteria:
- Severe comorbidity or leukemia associated complications
- Late relapse of pediatric ALL or ALL as second malignancy
- Cytostatic pre-treatment
- Pregnancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of
the patient
- Participation in other clinical trials interfering with the study therapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Remission rate, Remission duration, Disease free survival,Overall survival
Principal Investigator
Dieter Hoelzer, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital of Frankfurt, Medical Dept. II
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
GMALL01
NCT ID:
NCT00198991
Start Date:
April 2003
Completion Date:
Related Keywords:
- Adult Acute Lymphocytic Leukemia
- ALL
- Treatment
- de novo
- Minimal residual disease
- Adult
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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