NCT00140660

Brief Summary

This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
223

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3

Geographic Reach
3 countries

11 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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

4.6 years

First QC Date

August 31, 2005

Last Update Submit

March 9, 2017

Conditions

Diffuse Large Cell Lymphoma

Keywords

lymphoma, diffuse large B-cellrituximabchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Event-free survival (EFS)

    events defined as death from any cause, relapse for complete responders (CR) and unconfirmed complete responders (CRu), progression during and after treatment and change of therapy.

    4 years

Secondary Outcomes (4)

  • Response rate at the end of the treatment

    6 months

  • Disease-free survival for complete responders

    4 years

  • Overall survival

    4 years

  • additionnal toxicities with R-ACVBP

    4 years

Study Arms (2)

R-ACVBP

EXPERIMENTAL

addition of rituximab to standard ACVBP chemotherapy

Drug: rituximab

ACVBP

NO INTERVENTION

standard ACVBP chemotherapy

Interventions

rituximabDRUG

375 mg/m2 on D1

R-ACVBP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
  • Age from 18 to 65 years.
  • Patient not previously treated.
  • Ann Arbor stage I or II.
  • ECOG performance status \< 2.
  • Normal LDH.
  • Negative HIV, HBV and HCV serologies 4 weeks (except after vaccination).
  • Having previously signed a written informed consent.

You may not qualify if:

  • Any other histological type of lymphoma. vAny history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in lymph node may be included.
  • Central nervous system or meningeal involvement by lymphoma.
  • Contra-indication to any drug contained in the chemotherapy regimens.
  • Poor renal function (creatinin level \>150 mmol/l), poor hepatic function (total bilirubin level \>30 mmol/l, transaminases \>2.5 maximum normal level).
  • Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l.
  • 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).
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Pregnant or lactating women
  • Adult patient under tutelage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Groupe d'Etude des Lymphomes de l'adulte

Mont-Godinne, Belgium

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hématologie CHU de Lille

Lille, 59000, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Hématologie Adultes - Hôpital Necker

Paris, 75743, France

Location

Service d'Hématologie - Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Robert Debré

Reims, 51092, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Hématologie CHU Purpan

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Centre Pluridisciplinaire d'Oncologie, CHUV

Lausanne, 1011, Switzerland

Location

Related Publications (5)

  • Reyes F, Lepage E, Ganem G, Molina TJ, Brice P, Coiffier B, Morel P, Ferme C, Bosly A, Lederlin P, Laurent G, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA). ACVBP versus CHOP plus radiotherapy for localized aggressive lymphoma. N Engl J Med. 2005 Mar 24;352(12):1197-205. doi: 10.1056/NEJMoa042040.

    PMID: 15788496BACKGROUND

  • Miller TP, Dahlberg S, Cassady JR, Adelstein DJ, Spier CM, Grogan TM, LeBlanc M, Carlin S, Chase E, Fisher RI. Chemotherapy alone compared with chemotherapy plus radiotherapy for localized intermediate- and high-grade non-Hodgkin's lymphoma. N Engl J Med. 1998 Jul 2;339(1):21-6. doi: 10.1056/NEJM199807023390104.

    PMID: 9647875BACKGROUND

  • Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Ferme C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. doi: 10.1200/JCO.2005.09.131. Epub 2005 May 2.

    PMID: 15867204BACKGROUND

  • Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. doi: 10.1182/blood-2003-02-0542. Epub 2003 Aug 14.

    PMID: 12920037BACKGROUND

  • Copie-Bergman C, Cuilliere-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

    PMID: 26373676DERIVED

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

  • Nicolas Ketterer, MD

    Lymphoma Study Association

    PRINCIPAL INVESTIGATOR

  • Felix Reyes, MD

    Lymphoma Study Association

    STUDY DIRECTOR

  • Hervé Tilly, MD

    Lymphoma Study Association

    STUDY CHAIR

  • Corinne Haioun, MD

    Lymphoma Study Association

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

December 1, 2003

Primary Completion

July 1, 2008

Study Completion

April 1, 2012

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)BE(1)FR(9)