Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00797810|
Recruitment Status : Unknown
Verified September 2009 by University of Bologna.
Recruitment status was: Recruiting
First Posted : November 25, 2008
Last Update Posted : September 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Non-Hodgkin's Lymphoma||Drug: Rituximab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults|
|Study Start Date :||December 2006|
Other Name: Cyclophosphamide, Prednisone, Dexamethasone, Vincristine, Ifosfamide, Cytarabine, Adriamycin, G-CSF
- Test of the tolerability and efficacy of new therapy elements to improve remission
- Rates, overall survival and remission duration
- Administration of anti-CD20 (rituximab ®) together with combination chemotherapy
- Combination therapy with high-dose methotrexate and high-dose cytarabine together with conventional cytostatic agents (cycle C)
- Prophylactic administration of G-CSF after every cycle of chemotherapy
- Localised irradiation after 6 cycles in mediastinal tumor cases, CNS involvement and residual tumor
- Test of the age-adapted therapy stratification according to biological age
- (18< age <55)
- Definition of prognostic factors
- Setting up of a central reference pathology panel
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797810
|Contact: Giovanni Martinelli, MDfirstname.lastname@example.org|
|Institute of Haematology "L. e A. Seragnoli"||Recruiting|
|Contact: Giovanni Martinelli, MD|
|Principal Investigator:||Giovanni Martinelli, MD||Institute of Haematology "L.e A. Seragnoli" Bologne-Italy|