Status:
TERMINATED
ACVBP Versus ACVBP Plus Rituximab in Low Risk Localized Diffuse Large B-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Amgen
Conditions:
Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.
Detailed Description
Approximately 30 to 40% of diffuse large B cell lymphomas are localized at diagnosis (stage I-II). Until the seventies, radiotherapy was used as the single modality to treat these localized stages but...
Eligibility Criteria
Inclusion
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
- Age from 18 to 65 years.
- Patient not previously treated.
- Ann Arbor stage I or II.
- ECOG performance status \< 2.
- Normal LDH.
- 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. vAny history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in lymph node may be included.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level \>150 mmol/l), poor hepatic function (total bilirubin level \>30 mmol/l, transaminases \>2.5 maximum normal level).
- Poor bone marrow reserve as defined by neutrophils \< 1.5 G/l or platelets \< 100 G/l.
- 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
- Adult patient under tutelage.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT00140660
Start Date
December 1 2003
End Date
April 1 2012
Last Update
March 13 2017
Active Locations (11)
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1
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
2
Hôpital Henri Mondor
Créteil, France, 94010
3
Hématologie CHU de Lille
Lille, France, 59000
4
Hôpital Saint Louis
Paris, France, 75010