ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00144807
First received: September 2, 2005
Last updated: August 26, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Diffuse Large Cell Lymphoma
Drug: rituximab
Drug: doxorubicin
Drug: cyclophosphamide
Procedure: autologous stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Complete remission rate (CR + CRu) [ Time Frame: 4 cycles of ACVBP ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival and overall survival of patients submitted to autologous transplant and of the entire study population [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: December 2003
Estimated Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This phase II non randomized study is based on the results of the LNH 98-5, LNH 87-2, LNH 93-3 and LNH 98-3B studies.

To date, the ACVBP regimen is considered as the reference induction treatment of the GELA in patients with 2-3 adverse prognostic factors. Indeed neither NCVBP regimen (LNH87-2) nor ECVBP (LNH93-3) led to increase the complete remission rate. More recently, the addition of etoposide to doxorubicin and cyclophosphamide (LNH98-3B) did not enhanced the complete remission rate with more toxicity. In patients < 60 years with 2-3 adverse prognostic factors the complete remission rate remained less than 65% in all these studies. Consequently, increasing the quality of response remains a major goal in this group of young patients with adverse prognostic factors.

It has been shown that the addition of rituximab to CHOP regimen significantly improved the CR rate in elderly patients with previously untreated large B-cell lymphoma when compared with CHOP alone without additional toxicities. Moreover, event-free survival and overall survival were found to be longer in the R-CHOP group. The present trial will evaluate the response rate obtained after four cycles of ACVBP combined to rituximab (R-ACVBP) before high dose therapy consolidative treatment in this group of higher risk patients.

The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell support was beneficial to high risk patients in good response after a full induction phase. The long-term results of this randomised study prompted us to consider high dose therapy as the best consolidative option for these patients.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144807

Locations
Belgium
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
France
Polyclinique Bordeaux Nord
Bordeaux, France, 33300
Hôpital Henri Mondor
Créteil, France, 94010
Hématologie CHU de Lille
Lille, France, 59000
Centre Léon Bérard
Lyon, France, 69008
Hématologie Adultes - Hôpital Necker
Paris, France, 75743
Hôpital Saint Louis
Paris, France, 75010
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Centre Hospitalier Robert Debré
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Hématologie CHU Purpan
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France
Switzerland
Schweirische Arbeitsgruppe fur klinische Krebsforschung
Lausanne, Switzerland
Sponsors and Collaborators
Lymphoma Study Association
Investigators
Principal Investigator: Olivier Fitoussi, MD Lymphoma Study Association
Study Director: Christian Gisselbrecht, MD Lymphoma Study Association
Study Chair: Corinne Haioun, MD Lymphoma Study Association
Study Chair: Hervé Tilly, MD Lymphoma Study Association
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hervé Tilly, GELA
ClinicalTrials.gov Identifier: NCT00144807     History of Changes
Other Study ID Numbers: LNH03-3B
Study First Received: September 2, 2005
Last Updated: August 26, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
lymphoma, diffuse large B-cell
rituximab
chemotherapy
autologous stem cell transplant

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 16, 2014