Clinical Trial: Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-grade Lymphoma in Adults
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
Brief Summary: The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.
Detailed Summary:
Sponsor: Nicola Goekbuget
Current Primary Outcome:
- Remission rate
- Remission duration
- Disease free survival
- Overall survival
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Dose and time compliance
- Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
- Death under therapy and in complete remission (CR)
- Localisations of relapse
Original Secondary Outcome:
- Dose and time compliance
- -Toxicity according to NCI-CTC
- -Death under therapy and in CR
- Localisations of relapse
Information By: Johann Wolfgang Goethe University Hospital
Dates:
Date Received: September 12, 2005
Date Started: July 2002
Date Completion:
Last Updated: August 4, 2016
Last Verified: August 2016