We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169143
First Posted: September 15, 2005
Last Update Posted: September 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amgen
Information provided by:
Lymphoma Study Association
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00169143     History of Changes
Other Study ID Numbers: LNH 03-39B
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: September 8, 2006
Last Verified: September 2006

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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bleomycin
Cyclophosphamide
Doxorubicin
Prednisone
Vindesine
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents