German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)
Study Details
Study Description
Brief Summary
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on the results of MRD evaluation.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: All patients All patients are treated upfront according to one arm |
Drug: Cyclophosphamide
Cytostatic drug
Drug: Dexamethasone
Antileukemic drug
Drug: Vincristine
Cytostatic drug
Drug: Daunorubicin
Cytostatic drug
Drug: Asparaginase
Cytostatic drug
Other Names:
Drug: Methotrexate
Cytostatic drug
Drug: Cytarabine
Cytostatic drug
Drug: Mercaptopurine
Cytostatic drug
Drug: G-CSF
Growth factor
Drug: Vindesine
Cytostatic drug
Drug: Etoposide
Cytostatic drug
Other Names:
Drug: Prednisolone
Antileukemic drug
Drug: Adriamycin
Cytostatic drug
Drug: Thioguanine
Cytostatic drug
Drug: Teniposide
Cytostatic drug
Procedure: CNS irradiation
Cytostatic drug
Procedure: Mediastinal Irradiation
Irradiation
Procedure: Stem cell transplantation (SCT)
Stem cell transplantation
Drug: Idarubicin
Cytostatic drug
Drug: Fludarabine
Cytostatic drug
Drug: Cladribine
Cytostatic drug
|
Outcome Measures
Primary Outcome Measures
- Remission rate [day 46]
Rate of patients with complete remission
- Remission duration [up to 10 years]
Rate and probability of patients with ongoing remission after prior achievement of remission
- Disease free survival [up to 10 years]
Rate and probability of patients remaining disease free i.e without relapse, death in CR or secondary malignancy
- Overall survival [up to 10 years]
Rate and probability of patients remaining alive
Secondary Outcome Measures
- Realisation of Stem cell transplantation (SCT) [up to 10 years]
Rate of patients receiving an SCT
- Toxicity according to WHO/CTCAE [after each cycle up to 2.5 years]
Rate of adverse events according to WHO/CTCAE (cycle duration in this complex protocol is variable and cannot be specified)
- Response assessment based on MRD [up to 5 years]
Rate of MRD response after specific cycles
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Frankfurt, Medical Dept. II | Frankfurt | Germany | 60590 |
Sponsors and Collaborators
- Goethe University
- Deutsche Krebshilfe e.V., Bonn (Germany)
- German Federal Ministry of Education and Research
Investigators
- Study Chair: Dieter Hoelzer, MD,PhD, University Hospital of Frankfurt, Medical Dept. II
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- GMALL01