drugset / Trial / NCT00797810

Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

NCT00797810

Phase 4 Unknown 25 enrolled University of Bologna
Non-randomizedSingle-groupOpen-labelTreatment

Summary

All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group * Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3). * Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement. * In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years * The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1\*, B1\*,A2\*, B2\*, A3\*, B3\*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.

Timeline

Start
2006-12
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody