German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
Information source: Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Acute Lymphocytic Leukemia
Intervention: Asparaginase (Drug); Vincristine (Drug); Daunorubicin, Adriamycin (Drug); Cyclophosphamide (Drug); Ifosfamide (Drug); Cytarabine (Drug); Mitoxantrone (Drug); Methotrexate (Drug); 6-Mercaptopurine (Drug); 6-Thioguanine (Drug); VM26 (Drug); Dexamethasone / Prednisolone (Drug); CNS Irradiation (Procedure); Mediastinal Irradiation (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 of Frankfurt, Medical Department II
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',
Clinical Details
Official title: Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: remission rate, disease free survival, overall survival
Secondary outcome: death in induction, toxicity, time and dose compliance
Eligibility
Minimum age: 15 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute Lymphocytic Leukemia
- Age 15 - 65 years
Exclusion Criteria:
- Serious secondary diseases which may compromise intensified chemotherapeutical
treatment
- Serious psychiatric diseases, which may compromise compliance with therapy
- HIV-1 or HIV-2 Infection
- Pretreatment > 2 weeks or chemotherapy other than Vincristine and Steroids
- Patients without central diagnosis who cannot be allocated to a risk group
Locations and Contacts
University Hospital, Medical Dept. II, Frankfurt, Germany
Additional Information
Starting date: April 1993
Last updated: May 16, 2008
|
