Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00169143
First received: September 12, 2005
Last updated: September 6, 2006
Last verified: September 2006
  Purpose

Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).


Condition Intervention Phase
Untreated CD20-Positive Large B-Cell Lymphoma
Drug: Rituximab + ACVBP regimen plus Pegfilgrastim
Procedure: Autologous stem cell transplant
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 R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma (Age-Adjusted Ipi >or= 2)

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • To evaluate the optimal combined dose intensity of the drug regimen

Secondary Outcome Measures:
  • Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival

Estimated Enrollment: 60
Study Start Date: May 2004
Estimated Study Completion Date: January 2007
Detailed Description:

This is a phase II, multicentric, open-label, non-randomized study, evaluating the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI), and eligible for transplant.

It is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a group sequential manner one planned interim analysis.

The duration of the treatment period is approximately 26 weeks and patients are followed until Death.

The total Duration of the study is expected to be 2.5 years.

  Eligibility

Ages Eligible for Study:   18 Years to 61 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 >18 and < 61 years, eligible for transplant.
  • Patient not previously treated.
  • With at least two prognostic factors of the Aa-IPI.
  • With a minimum life expectancy of 3 months.
  • Creatinin level ≤ 150mmol/l, total bilirubin level  30mmol/l and transaminases  2.5 maximum normal level, unless abnormalities are related to the lymphoma.
  • Neutrophils > 1.5 G/l and platelets > 100 G/l, unless if patient has a bone marrow infiltration.
  • Negative HIV, HBV and HCV serologies  4 weeks (except after vaccination).
  • Having previously signed a written informed consent.

Exclusion Criteria:

  • 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.
  • 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 or women of childbearing potential not currently practicing an adequate method of contraception.
  • 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: NCT00169143

Locations
France
Hôpital Henri Mondor
Créteil, France
Service d'Hématologie Clinique - CHU Le Bocage
Dijon, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandoeuvre-les-Nancy, France
Sponsors and Collaborators
Lymphoma Study Association
Amgen
Investigators
Study Chair: Corinne Haioun, MD Hôpital Henri Mondor, Créteil, France
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00169143     History of Changes
Other Study ID Numbers: LNH 03-39B
Study First Received: September 12, 2005
Last Updated: September 6, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
Diffuse large B cell lymphoma
Pegfilgrastim
Autotransplant

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bleomycin
Cyclophosphamide
Doxorubicin
Prednisone
Vindesine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 23, 2014