German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)

Phase 4

Completed

• Conditions: Adult Acute Lymphocytic Leukemia

• Registration Number: NCT00199069
• Lead Sponsor: Goethe University

Brief 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',

Detailed Description

Not available

Study Timeline

• Study Start: 1993-04
• Primary Completion: 1999-01
• Study Completion: 2001-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
remission rate, disease free survival, overall survival

Secondary Outcome Measures

Name	Time	Method
death in induction, toxicity, time and dose compliance

Trial Locations

Locations (1)

University Hospital, Medical Dept. II; 🇩🇪 Frankfurt, Germany