Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
Phase 4
Completed
- Conditions
- Adult Acute Lymphocytic Leukemia
- Registration Number
- NCT00199004
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- Brief Summary
The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy in combination with rituximab in CD20 positive standard risk patients. Thereafter patients receive additional consolidation and reinduction cycles combined with rituximab. In parallel minimal residual disease is evaluated. After six months and one year the decision on intensification or discontinuation of therapy is made based on results of MRD evaluation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- B-precursor ALL (common / pre B-ALL)
- Standard risk
- CD20 expression >20%
- Ph/BCR-ABL negative
- Age 15-65 years (55-65 if biologically younger)
- Written informed consent
Exclusion Criteria
- Severe complications due to leukemia or secondary illnesses
- Late relapse of childhood ALL
- Cytostatic pretreatment
- Pregnancy
- Severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent
- Known severe allergy to foreign proteins
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival
- Secondary Outcome Measures
Name Time Method Dose and time compliance, Toxicity according to WHO, Death in induction and CR, Course of MRD
Trial Locations
- Locations (1)
University Hospital of Frankfurt, Medical Dept. II
🇩🇪Frankfurt, Germany