Study of Mantle Cell Lymphoma Treatment by RiBVD

NCT01457144 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-03-16

No results posted yet for this study

Summary

Study of First line mantle cell lymphoma treatment by Rituximab, Velcade, Bendamustine and Dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.

Conditions

Interventions

DRUG

RiBVD

Every cycle: Rituximab intravenous infusion dosage 375 mg/m² day 1 Bendamustine direct intervenous 90 mg/m² day 1 and day 2 Velcade®subcutaneous 1,3 mg/m² day 1,4, 8 and 11 dexamethasone 40 mg IVD on day 2

Sponsors & Collaborators

  • Lymphoma Study Association

    collaborator OTHER
  • Janssen-Cilag Ltd.

    collaborator INDUSTRY
  • Mundipharma Pte Ltd.

    collaborator INDUSTRY
  • Roche Pharma AG

    collaborator INDUSTRY
  • Chugai Pharma Europe Ltd.

    collaborator INDUSTRY
  • French Innovative Leukemia Organisation

    lead OTHER

Principal Investigators

  • Rémy GRESSIN, MD · Groupe Est Ouest des Leucémies et autres Maladies du Sand

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-09-30
Completion
2016-03-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01457144 on ClinicalTrials.gov