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

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

ACVBP

ACE

rituximab

Autologous stem cell transplant

About this trial

This is an interventional treatment trial for CD20-Positive Large B-Cell Lymphoma focused on measuring Diffuse large B cell lymphoma, Rituximab, Autotransplant

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hôpital Henri Mondor
Hôpital Saint Louis
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Centre Henri Becquerel
CHRU de Nancy Brabois

Outcomes

Primary Outcome Measures

- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT

Secondary Outcome Measures

- 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

Full Information

NCT ID

NCT00169169

First Posted

September 13, 2005

Last Updated

September 13, 2005

Sponsor

Lymphoma Study Association

1. Study Identification

Unique Protocol Identification Number

NCT00169169

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Terminated

Study Start Date

October 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Lymphoma Study Association

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CD20-Positive Large B-Cell Lymphoma

Keywords

Diffuse large B cell lymphoma, Rituximab, Autotransplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

430 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ACVBP

Intervention Type

Drug

Intervention Name(s)

ACE

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Type

Procedure

Intervention Name(s)

Autologous stem cell transplant

Primary Outcome Measure Information:

Title

- To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT

Secondary Outcome Measure Information:

Title

- To compare response rate to induction treatments (ACVBP vs AC/ACE).

Title

- To evaluate response rate at the end of treatment.

Title

- To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)

Title

- To evaluate the safety and tolerability of Rituximab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corinne Haioun

Organizational Affiliation

Hôpital Henri Mondor, Créteil, France

Official's Role

Study Chair

Facility Information:

Facility Name

Hôpital Henri Mondor

City

Créteil

Country

France

Facility Name

Hôpital Saint Louis

City

Paris

Country

France

Facility Name

Service d'Hématologie - Centre Hospitalier Lyon-Sud

City

Pierre-Bénite cedex

Country

France

Facility Name

Centre Henri Becquerel

City

Rouen

Country

France

Facility Name

CHRU de Nancy Brabois

City

Vandoeuvre-les-Nancy

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

10944137

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, 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.

Results Reference

background

PubMed Identifier

9731049

Citation

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.

Results Reference

background

Links:

URL

http://www.gela.org

Description

Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)

CD20-Positive Large B-Cell Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial