Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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