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

August 21, 2018 updated by: Lymphoma Study Association

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (Coiffier et al NEJM 2002). It has been observed in almost all histological type of B-cell lymphomas. No significant increase of toxicity was observed especially in the most used regimen CHOP and the association R-CHOP is a standard for most B-cell malignancies CD20 positive.

However, in patients with diffuse large cell lymphoma progress should be made as the complete response rate is below 75% in most situation and in low grade lymphoma, although patients respond well to chemotherapy complete remission rate averaged generally 50% (Marcus et al 2003), Czuczman et al 1999) .

There is a need to improve this association with new innovative agent. Before running randomized study it is important to evaluate the like hood of getting improvement by phase 2 study testing tolerance and efficacy on a well established regimen.

Bortezomib (Velcade formerly PS 341) is a proteasome inhibitor which has shown promising activity in the treatment of refractory myeloma. As single agent in indolent lymphomas, administered twice per weeks for 2 weeks followed by one week rest period it has already showed activity in phase 2 study. It is well tolerated and main toxicity was neuropathy and thrombocytopenia.

Proteasome inhibitors can act through multiple mechanisms to arrest tumor growth, tumor spread, and angiogenesis. In vitro studies have shown a synergistic effect of the association of Velcade and doxorubicin on myeloma cell lines resistant to chemotherapy.

Association of Velcade to standard chemotherapy regimen is under study with the aim of improving on the results.

Association of Velcade to one of the most efficient treatment of B-cell lymphoma, R-CHOP, might increase the response rate.

However, different schedules should be explored in order to better appreciate efficacy and toxicity.

This randomized phase 2 study is designed to evaluate the response rate and the toxicity of two schedules of administration of Velcade in association with R-CHOP. The aim of the study is to establish a well tolerated regimen giving a response rate in the limit upper/lower of what is observed with conventional R-CHOP used in all the different histological subtypes of B cell lymphomas patients requiring treatment.

The heterogeneity of the population will preclude any meaningful subgroup analysis.

It is important to evaluate tolerability before exploring the efficacy of this new regimen in large randomized studies or in specific phases II study which will need 50 patients for each subgroup of patients.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Pierre Bénite, France, 69310
        • Hopital Lyon Sud
    • Paris 10
      • Paris, Paris 10, France, 75475
        • Hopital Saint-Louis
    • Villejuif Cedex
      • Villejuif, Villejuif Cedex, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of complete remission
Time Frame: 1 year
1 year
Number of SAE
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Progression free survival
Time Frame: 1 year
1 year
Duration of response
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Collaborators

Association pour le Développement de la Recherche Clinique et Informatique en Onco-Hématologie

Investigators

  • Principal Investigator: Christian Gisselbrecht, MD PHD, Lymphoma Study Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-CHOP VELCADE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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