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

Sponsors and Collaborators:	Groupe d'Etudes de Lymphomes de L'Adulte Amgen
Information provided by:	Groupe d'Etudes de Lymphomes de L'Adulte
ClinicalTrials.gov Identifier:	NCT00169143

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 II

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

Further study details as provided by Groupe d'Etudes de Lymphomes de L'Adulte:

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

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
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandoeuvre-les-Nancy, France
Hôpital Saint Louis
Paris, France

Sponsors and Collaborators

Groupe d'Etudes de Lymphomes de L'Adulte

Amgen

Investigators

Study Chair:

Corinne Haioun, MD

Hôpital Henri Mondor, Créteil, France

More Information

Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french) This link exits the ClinicalTrials.gov site

Publications:

Green MD, Koelbl H, Baselga J, Galid A, Guillem V, Gascon P, Siena S, Lalisang RI, Samonigg H, Clemens MR, Zani V, Liang BC, Renwick J, Piccart MJ; International Pegfilgrastim 749 Study Group. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003 Jan;14(1):29-35.

Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31.

Vose JM, Crump M, Lazarus H, Emmanouilides C, Schenkein D, Moore J, Frankel S, Flinn I, Lovelace W, Hackett J, Liang BC. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol. 2003 Feb 1;21(3):514-9.

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.

Study ID Numbers:	LNH 03-39B
Study First Received:	September 12, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00169143
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe d'Etudes de Lymphomes de L'Adulte:

Diffuse large B cell lymphoma
Pegfilgrastim
Autotransplant

Study placed in the following topic categories:

Lymphoma, large-cell
Lymphoma, B-Cell
Lymphatic Diseases
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders

Rituximab
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009