Status:
COMPLETED
Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Amgen
Conditions:
Untreated CD20-positive Large B-cell Lymphoma
Eligibility:
All Genders
18-61 years
Phase:
PHASE2
Brief Summary
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 pres...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00169143
Start Date
May 1 2004
End Date
January 1 2007
Last Update
August 23 2018
Active Locations (6)
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1
Hôpital Henri Mondor
Créteil, France
2
Service d'Hématologie Clinique - CHU Le Bocage
Dijon, France
3
Hôpital Saint Louis
Paris, France
4
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France