- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169169
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
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).
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Créteil, France
- Hôpital Henri Mondor
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Paris, France
- Hôpital Saint Louis
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Pierre-Bénite cedex, France
- Service d'Hématologie - Centre Hospitalier Lyon-Sud
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Rouen, France
- Centre Henri Becquerel
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Vandoeuvre-les-Nancy, France
- CHRU de NANCY BRABOIS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT
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Secondary Outcome Measures
Outcome Measure |
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- To compare response rate to induction treatments (ACVBP vs AC/ACE).
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- To evaluate response rate at the end of treatment.
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- To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
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- To evaluate the safety and tolerability of Rituximab
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Corinne Haioun, Hôpital Henri Mondor, Créteil, France
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- LNH-98.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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