Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01646021
Phase
PHASE3
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    560 mg once daily continuous (without interruption) by mouth for 21-day cycles
  • Temsirolimus — DRUG
    175 mg once daily intravenous infusion on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each 21-day cycle

Study Details

The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.

Key Dates

Start date
Dec 10, 2012
Status verified
Dec 2017
Primary completion
Jun 5, 2015
Completion
Dec 15, 2016

Study Design

Enrollment
280 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib
  • Experimental: Temsirolimus

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months) ]

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