R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

NCT00135499 | Terminated Phase 3

• 1 other identifier: LNH01-5B
• Study Type: interventional
• Target: 138
• Locations: 3 countries
• Sites: 8

Brief Summary

The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

Conditions

Lymphoma, Large-Cell, Diffuse

Keywords

Lymphoma; chemotherapy; rituximab

Outcome Measures

Primary Outcomes (1)

• event free survival

  percentage of patients alive with no event

  8 years (end of study)

Secondary Outcomes (7)

• complete response rate

  8 years (end of study)

• progression rate

  8 years (end of study)

• relapse rate

  8 years (end of study)

• disease-free survival for complete responders

  8 years (end of study)

• overall survival

  8 years (end of study)

Study Arms (2)

R-ACVBP

EXPERIMENTAL

Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone

Drug: Rituximab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vindesine; Drug: Bleomycin; Drug: Prednisone

R-CHOP

ACTIVE COMPARATOR

Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone

Drug: Rituximab; Drug: Prednisone; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Vincristine

Interventions

Rituximab DRUG

375 mg/m², D1, 4 cycles

R-ACVBP; R-CHOP

Doxorubicin DRUG

75 mg/m², D1, 4 cycles

R-ACVBP

Cyclophosphamide DRUG

1200 mg/m², D1, 4 cycles

R-ACVBP

Vindesine DRUG

2 mg/m², D1, D5, 4 cycles

R-ACVBP

Bleomycin DRUG

10 mg, D1, D5, 4 cycles

R-ACVBP

Prednisone DRUG

60 mg, D1-D5, 4 cycles

R-ACVBP

Vincristine DRUG

1.4 mg/m², D1, 4 cycles

R-CHOP

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
• Aged from 60 to 65 years.
• Not previously treated.
• Ann Arbor stage II, III, IV.
• ECOG performance status 0 to 2.
• Minimum life expectancy of 3 months.
• Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies test 4 weeks (except after vaccination).
• Having previously signed a written informed consent.

You may not qualify if:

• T-cell lymphoma.
• 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.
• Any serious active disease (according to the investigator's decision).
• Poor renal function (creatinine level\>150micromol/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\<1.5G/l or platelets\<100G/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.
• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
• Adult patient under tutelage.

Sponsors & Collaborators

• Lymphoma Study Association: lead
• Fondation ARC: collaborator

Study Sites (8)

Groupe d'Etude des Lymphomes de l'adulte

Yvoir, Belgium

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital Saint Louis

Paris, 75010, 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

Institut Gustave Roussy

Villejuif, France

Location

Schweirische Arbeitsgruppe fur klinische Krebsforschung

Lausanne, Switzerland

Location

Related Publications (4)

• 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: 12920037 BACKGROUND

• Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.

  PMID: 11807147 BACKGROUND

• 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: 27282998 DERIVED

• 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: 26373676 DERIVED

Related Links

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

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

Rituximab; Doxorubicin; Cyclophosphamide; Vindesine; Bleomycin; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Glycopeptides; Glycoconjugates; Peptides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Herve Tilly, MD

  Lymphoma Study Association

  PRINCIPAL INVESTIGATOR

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 25, 2005
• First Posted: August 26, 2005
• Study Start: October 16, 2001
• Primary Completion: April 27, 2010
• Study Completion: April 27, 2010
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

CH (1); BE (1); FR (6)