Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)
Lead SponsorJ. W. Goethe University
StatusCompleted No Results Posted
Intervention/Treatmenturea prednisone doxorubicin naltrexone vincristine ifosfamide cyclophosphamide rituximab etoposide sargramostim cytarabine ...
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.
This is a single arm trial with complex chemotherapy (6 cycles) stratified by age, subtype (Burkitt-leukemia vs Burkitt-lymphoma) and initial involvement
Inclusion Criteria: Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma Age > 15 years Written informed consent Exclusion Criteria: Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected HIV infection Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy Known severe allergy to foreign proteins Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy. Pregnancy or nursing Participation in other studies that interfere with study therapy