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A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma

NCT00136591 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2010-10-26

No results posted yet for this study

Summary

This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.

Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.

Conditions

Interventions

DRUG

Bortezomib

Arm A: a 21-day cycle of 1.5 mg/m2 Velcade™ twice weekly for 2 weeks. Days 1, 4, 8, and 11 of a 21-day cycle

DRUG

Bortezomib

Arm B: a 35-day cycle of 1.6 mg/m2 Velcade™once weekly for 4 weeks. Days 1, 8, 15, and 22 of a 35-day cycle. Subjects in this treatment arm will receive a total of 6 cycles of treatment, approximately 30 weeks.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    collaborator INDUSTRY

  • Lymphoma Study Association

    lead OTHER

Principal Investigators

  • Bertrand Coiffier, MD · Hospices Civils de Lyon, Lyon, France

  • Vincent Ribrag, MD · Institut Gustave Roussy, Villejuif, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT00136591 on ClinicalTrials.gov