NCT00169169

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

CD20-Positive Large B-Cell Lymphoma

Keywords

Diffuse large B cell lymphomaRituximabAutotransplant

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • - 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

Interventions

ACVBPDRUG
ACEDRUG
rituximabDRUG
Autologous stem cell transplantPROCEDURE

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Henri Mondor

Créteil, France

Location

Hôpital Saint Louis

Paris, France

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

Location

Centre Henri Becquerel

Rouen, France

Location

CHRU de Nancy Brabois

Vandœuvre-lès-Nancy, France

Location

Related Publications (2)

  • 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.

    PMID: 10944137BACKGROUND

  • 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.

    PMID: 9731049BACKGROUND

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Corinne Haioun

    Hôpital Henri Mondor, Créteil, France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

October 1, 1999

Study Completion

August 1, 2005

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

FR(5)