German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)

Phase 4

Completed

• Conditions: Adult Acute Lymphocytic Leukemia

• Registration Number: NCT00199056
• Lead Sponsor: Goethe University

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. A MRD based risk stratification and treatment decision is developed.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-10
• Primary Completion: 2003-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Study Completion: 2005-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Remission rate,Remission duration,Disease free survival,Overall survival

Secondary Outcome Measures

Name	Time	Method
Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD

Trial Locations

Locations (1)

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