Status:
COMPLETED
Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Association pour le Développement de la Recherche Clinique et Informatique en Onco-Hématologie
Conditions:
B Cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the response rate and toxicity of the association R-CHOP with two schedules of administration of Velcade, in B-cell CD 20 + lymphoma patients, aged f...
Detailed Description
The association of the monoclonal antibody Rituximab to chemotherapy regimen of B-cell lymphoma is associated with an increase response rate and event free survival when compared to chemotherapy alone...
Eligibility Criteria
Inclusion
- • Patients with one of the following B-cell Lymphoma CD 20 positive : Mantle cell, Marginal zone, lymphocytic, follicular requiring treatment, Histological transformation from low grade to high grade, diffuse large cell without adverse prognostic factors defined by the international prognostic index (IPI)
- Aged from 18 to 80 years
- Untreated with chemotherapy except with Chlorambucil or Cyclophosphamide per os alone less than 6 months
- Previous radiotherapy except if localized
- Performance status \< 3
- Signed inform consent
Exclusion
- Other type of lymphomas: Burkitt, T cell, CD 20 negative
- Central nervous system or meningeal involvement
- Contraindication to any drug contained in the chemotherapy regimen
- HIV disease, active hepatitis B or C
- Treatment with polychemotherapy before except with Chlorambucil or Cyclophosphamide per os less than 6 months
- Prior extended radiotherapy
- Any serious active disease or co-morbid medical condition (according to investigator's decision )
- Renal deficiency (clearance \< 30 ml/mn), liver deficiency (bilirubin \> 30 mmol/l) unless related to lymphoma
- Neuropathy\> grade 2 within 14 days before enrollment
- Platelets \< 30.109/l within 14 days before enrollment
- Neutrophils \< 1.0 109/l within 14 days before enrollment
- Women with pregnancy or without adequate method of contraception
- Any history of active cancer during the last two years
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00169468
Start Date
January 1 2005
End Date
January 1 2006
Last Update
August 23 2018
Active Locations (4)
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1
Hôpital Saint-Louis
Paris, Paris 10, France, 75475
2
Institut Gustave Roussy
Villejuif, Villejuif Cedex, France, 94805
3
Hôpital Henri Mondor
Créteil, France, 94010
4
Hôpital Lyon Sud
Pierre-Bénite, France, 69310