Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
This study has been completed.
Sponsor:
Lymphoma Study Association
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
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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 |
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 | |
| 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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Rituximab Cyclophosphamide Bleomycin Doxorubicin Prednisone |
Vindesine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Antibiotics, Antineoplastic Immunosuppressive Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 21, 2013