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

Sponsor

Lymphoma Study Association (Other)

Overall Status

Terminated

CT.gov ID

NCT00169169

Collaborator

(none)

430

Enrollment

Locations

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Oct 1, 1999

Study Completion Date :

Aug 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Hôpital Henri Mondor	Créteil	France
2	Hôpital Saint Louis	Paris	France
3	Service d'Hématologie - Centre Hospitalier Lyon-Sud	Pierre-Bénite cedex	France
4	Centre Henri Becquerel	Rouen	France
5	CHRU de Nancy Brabois	Vandoeuvre-les-Nancy	France