A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01973387
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Up to 6 cycles (total of 8 doses administered by intravenous infusion): 375 mg/m2 on Day 1 of Cycle 1, 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); and 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
  • Ibrutinib — DRUG
    420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus rituximab in adult Asia Pacific region patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Key Dates

Start date
Oct 28, 2013
Status verified
Jun 2018
Primary completion
Dec 1, 2015
Completion
Aug 11, 2017

Study Design

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

Arms

  • Experimental: Treatment Arm A
  • Experimental: Treatment Arm B

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years) ]

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