CD20-Positive Large B-Cell Lymphoma Clinical Trial
Official title:
Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
| Status | Terminated |
| Enrollment | 430 |
| Est. completion date | August 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 59 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Henri Mondor | Créteil | |
| France | Hôpital Saint Louis | Paris | |
| France | Service d'Hématologie - Centre Hospitalier Lyon-Sud | Pierre-Bénite cedex | |
| France | Centre Henri Becquerel | Rouen | |
| France | CHRU de Nancy Brabois | Vandoeuvre-les-Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Lymphoma Study Association |
France,
Coiffier B, Haioun C, Ketterer N, Engert A, Tilly H, Ma D, Johnson P, Lister A, Feuring-Buske M, Radford JA, Capdeville R, Diehl V, Reyes F. Rituximab (anti-CD20 monoclonal antibody) for the treatment of patients with relapsing or refractory aggressive lymphoma: a multicenter phase II study. Blood. 1998 Sep 15;92(6):1927-32. — View Citation
Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Brière J, Gaulard P, Reyes F. Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: final analysis of the prospective LNH87-2 protocol--a groupe d'Etude des lymphomes de l'Adulte study. J Clin Oncol. 2000 Aug;18(16):3025-30. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT | |||
| Secondary | - To compare response rate to induction treatments (ACVBP vs AC/ACE). | |||
| Secondary | - To evaluate response rate at the end of treatment. | |||
| Secondary | - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing) | |||
| Secondary | - To evaluate the safety and tolerability of Rituximab |