Association of Velcade to R-CHOP in the Treatment of B Cell Lymphoma

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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 from 18 to 80 years

The goal is to get a response rate at least at what observed with R-CHOP alone and will be evaluates with a sequential test.

The other objective is to evaluate the toxicity

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborator: Association pour le Développement de la Recherche Clinique et Informatique en Onco-Hématologie
• Treatments: Bortezomib; Rituximab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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