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Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

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. Identifier: NCT00169169
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Information provided by:
Lymphoma Study Association

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.

Condition or disease Intervention/treatment Phase
CD20-Positive Large B-Cell Lymphoma Drug: ACVBP Drug: ACE Drug: rituximab Procedure: Autologous stem cell transplant Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Study Start Date : October 1999
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Primary Outcome Measures :
  1. - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT

Secondary Outcome Measures :
  1. - To compare response rate to induction treatments (ACVBP vs AC/ACE).
  2. - To evaluate response rate at the end of treatment.
  3. - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
  4. - To evaluate the safety and tolerability of Rituximab

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00169169

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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, France
Sponsors and Collaborators
Lymphoma Study Association
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Study Chair: Corinne Haioun Hôpital Henri Mondor, Créteil, France

Additional Information:
Layout table for additonal information Identifier: NCT00169169    
Other Study ID Numbers: LNH-98.3
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 2005
Last Verified: September 2005
Keywords provided by Lymphoma Study Association:
Diffuse large B cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents