German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)
Information source: Johann Wolfgang Goethe University Hospitals
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Acute Lymphocytic Leukemia
Intervention: Dexamethasone / Prednisolone (Drug); Cyclophosphamide (Drug); Methotrexate (Drug); Vincristine / Vindesine (Drug); Daunorubicin (Drug); Asparaginase (Drug); G-CSF (Drug); Cytarabine (Drug); 6-Mercaptopurine (Drug); VP16 (Drug); Adriamycin (Drug); Thioguanine (Drug); VM26 (Drug); Idarubicin (Drug); Fludarabine (Drug); Ifosfamide (Drug); CNS irradiation (Procedure); Mediastinal irradiation (if residual tumor) (Procedure); stem cell transplantation (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Johann Wolfgang Goethe University Hospitals Official(s) and/or principal investigator(s):
Dieter Hoelzer, MD,PhD, Study Chair, Affiliation: University Hospital Frankfurt, Medical Dept. II
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. A MRD
based risk stratification and treatment decision is developed.
Clinical Details
Official title: Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Remission rate,Remission duration,Disease free survival,Overall survival
Secondary outcome: Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD
Eligibility
Minimum age: 15 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T)
- Age 15-65 yrs (*55-65 years if biologically younger according to general condition)
Exclusion Criteria:
- Severe comorbidity
- Cytostatic pre-treatment
- Pregnancy
- Missing written informed consent
Locations and Contacts
University Hospital, Medical Dept. II, Frankfurt 60590, Germany
Additional Information
Starting date: October 1999
Last updated: May 16, 2008
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