Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
NCT ID: NCT00169169
Last Updated: 2005-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
430 participants
INTERVENTIONAL
1999-10-31
2005-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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ACVBP
ACE
rituximab
Autologous stem cell transplant
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
59 Years
ALL
No
Sponsors
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Lymphoma Study Association
OTHER
Principal Investigators
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Corinne Haioun
Role: STUDY_CHAIR
Hôpital Henri Mondor, Créteil, France
Locations
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Hôpital Henri Mondor
Créteil, , France
Hôpital Saint Louis
Paris, , France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
Centre Henri Becquerel
Rouen, , France
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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Haioun C, Lepage E, Gisselbrecht C, Salles G, Coiffier B, Brice P, Bosly A, Morel P, Nouvel C, Tilly H, Lederlin P, Sebban C, Briere 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. doi: 10.1200/JCO.2000.18.16.3025.
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.
Related Links
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Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)
Other Identifiers
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LNH-98.3
Identifier Type: -
Identifier Source: org_study_id