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An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma

NCT01902862 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2014-04-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy (effectiveness) and tolerability (how well a participant can stand a particular medicine or treatment; ability to be used) of bortezomib in combination with rituximab standard therapy (medicine or medical care given to a participant for a disease or condition) in participants with relapsed or refractory (not responding to treatment) follicular lymphoma (a cancer of the lymph nodes \[or tissues\] in follicle).

Conditions

  • Lymphoma, Follicular

Interventions

DRUG

Bortezomib

Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m\^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.

DRUG

Rituximab

Rituximab will be administered as intravenous infusion as 375 mg pert m\^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.

Sponsors & Collaborators

  • Janssen-Cilag G.m.b.H

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag G.m.b.H, Germany Clinical Trial · Janssen-Cilag G.m.b.H

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT01902862 on ClinicalTrials.gov