Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
- Sponsor
- Johann Wolfgang Goethe University Hospital
- Study ID
- NCT00199004
- Phase
- PHASE4
- Status
- Completed
Conditions
- Adult Acute Lymphocytic Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cyclophosphamide — DRUG
- Dexamethasone / Prednisolone — DRUG
- Vincristine — DRUG
- Daunorubicin — DRUG
- Asparaginase — DRUG
- Methotrexate — DRUG
- Cytarabine — DRUG
- Mercaptopurine — DRUG
- G-CSF — DRUG
- Vindesine — DRUG
- VP16 — DRUG
- Adriamycin — DRUG
- Thioguanine — DRUG
- VM26 — DRUG
- Rituximab — DRUG
- CNS irradiation — PROCEDURE
- Mediastinal irradiation (if residual TU) — PROCEDURE
- Stem cell transplantation — PROCEDURE
Study Details
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
Key Dates
- Start date
- Apr 30, 2004
- Status verified
- May 2008
- Primary completion
- Mar 31, 2009
- Completion
- Mar 31, 2009
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Remission rate (cytologic, Remission rate (molecular), Remission duration, Disease free survival, Overall survival