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