NCT00144807

Brief Summary

This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma

Trial Health

90
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_2

Geographic Reach
3 countries

13 active sites

Status
completed

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

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

4.8 years

First QC Date

September 2, 2005

Last Update Submit

September 1, 2015

Conditions

Diffuse Large Cell Lymphoma

Keywords

lymphoma, diffuse large B-cellrituximabchemotherapyautologous stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate (CR + CRu)

    4 cycles of ACVBP

    12 weeks

Secondary Outcomes (1)

  • Event-free survival and overall survival of patients submitted to autologous transplant and of the entire study population

    3 years

Study Arms (1)

R-AC

EXPERIMENTAL

rituximab + doxorubicin + cyclophosphamide + autologous stem cell transplantation

Drug: rituximabDrug: doxorubicinDrug: cyclophosphamideProcedure: autologous stem cell transplantation

Interventions

rituximabDRUG
R-AC
doxorubicinDRUG
R-AC
cyclophosphamideDRUG
R-AC
autologous stem cell transplantationPROCEDURE
R-AC

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).
  • Age from 18 to 59 years, eligible for transplant. Patient not previously treated. Age adjusted IPI = 2 or 3 With a minimum life expectancy of 3 months Negative HIV, HBV and HCV serologies \< 4 weeks (except after vaccination). Having signed a written informed consent.

You may not qualify if:

  • Any 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 bone marrow or 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) 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). 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 (13)

Groupe d'Etude des Lymphomes de l'adulte

Mont-Godinne, Belgium

Location

Polyclinique Bordeaux Nord

Bordeaux, 33300, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hématologie CHU de Lille

Lille, 59000, France

Location

Centre Léon Bérard

Lyon, 69008, 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

Schweirische Arbeitsgruppe fur klinische Krebsforschung

Lausanne, Switzerland

Location

Related Publications (6)

  • 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

  • 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

  • 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

  • Ghesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

    PMID: 27282998DERIVED

  • 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

  • Fitoussi O, Belhadj K, Mounier N, Parrens M, Tilly H, Salles G, Feugier P, Ferme C, Ysebaert L, Gabarre J, Herbrecht R, Janvier M, Van Den Neste E, Morschhauser F, Casasnovas O, Ghesquieres H, Anglaret B, Brechignac S, Haioun C, Gisselbrecht C. Survival impact of rituximab combined with ACVBP and upfront consolidation autotransplantation in high-risk diffuse large B-cell lymphoma for GELA. Haematologica. 2011 Aug;96(8):1136-43. doi: 10.3324/haematol.2010.038109. Epub 2011 May 5.

    PMID: 21546499DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

RituximabDoxorubicinCyclophosphamide

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 GlobulinsGlobulinsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Olivier Fitoussi, MD

    Lymphoma Study Association

    PRINCIPAL INVESTIGATOR

  • Christian Gisselbrecht, MD

    Lymphoma Study Association

    STUDY DIRECTOR

  • Corinne Haioun, MD

    Lymphoma Study Association

    STUDY CHAIR

  • Hervé Tilly, MD

    Lymphoma Study Association

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

December 1, 2003

Primary Completion

September 1, 2008

Study Completion

April 1, 2012

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

FR(11)CH(1)BE(1)