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

Sponsor
Janssen-Cilag G.m.b.H
Study ID
NCT01902862
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    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.
  • Rituximab — DRUG
    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.

Study Details

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).

Key Dates

Start date
Feb 28, 2006
Status verified
Mar 2014
Primary completion
Aug 31, 2007
Completion
Aug 31, 2007

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Time to Progression or Relapse [ Time Frame: Start of treatment (Day 1 of Cycle 1) up to Month 15 ]

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