CD20-Positive Large B-Cell Lymphoma
Conditions
Keywords
Diffuse large B cell lymphoma, Rituximab, Autotransplant
Brief summary
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
Detailed description
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma . The duration of the treatment period is approximately 25 weeks and patients are followed until Death. From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130). The final analysis was performed in June 2005.
Interventions
Sponsors
Lymphoma Study Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification). * Aged from 18 to 59 years, eligible for transplant. * Patient not previously treated. * Age adjusted International Prognostic Index equal to 2 or 3. * Having previously signed a written informed consent. * Women of childbearing potential currently practicing an adequate method of contraception.
Exclusion criteria
* Any other histological type of lymphoma. * Any history of treated or non-treated indolent lymphoma. * Central nervous system or meningeal involvement by lymphoma. * Contra-indication to any drug contained in the chemotherapy regimens. * Poor renal function (creatinin level\>150mmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l, unless related to bone marrow infiltration. * Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Any serious active disease (according to the investigator's decision). * HIV, HTLV1 or HBV related disease. * Any organ transplantation before inclusion. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare response rate to induction treatments (ACVBP vs AC/ACE). | — |
| - To evaluate response rate at the end of treatment. | — |
| - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing) | — |
| - To evaluate the safety and tolerability of Rituximab | — |
Countries
France
Outcome results
None listed