study of the bruton's tyrosine kinase (btk) inhibitor ibrutinib in participants with relapsed or refractory mantle cell lymphoma

Conditions: Lymphoma, Mantle-cell

Summary: the purpose of this study is to evaluate overall response rate (orr) (complete response \[cr\] rate plus partial response \[pr\] rate) of ibrutinib (imbruvica™; pci-32765; jnj-54179060), as assessed by an independent review committee (irc), in participants with relapsed or refractory mantle cell lymphoma (mcl-a cancer of the lymph nodes or tissues).

this is a phase 2, single-arm, open-label (all knew the intervention of study), and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to explore the efficacy, safety and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of ibrutinib in japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) mcl. the study will consist of a screening phase of 30 days prior to first dose of study drug followed by treatment phase and a post-treatment follow-up phase. participants will receive ibrutinib 560 milligram (mg) orally, once daily on a 28-day cycle until disease progression (or relapse if the participant achieved a cr), unacceptable toxicity, or study end, whichever occurs first. treatment phase will have disease assessments every 8 weeks up to 24 weeks after start of study drug, then every 12 weeks thereafter to assess efficacy up to 2 years after last participant enrolled. efficacy will primarily be evaluated by orr. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * diagnosis of mantle cell lymphoma ( mcl) must include morphology and expression of either cyclin d1 in association with one b-cell marker (for example, cluster of differentiation \[cd\] cd19, cd20, or paired box \[pax5\]) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (fish), or polymerase chain reaction (pcr) * received at least 1 prior lines of therapy for mcl (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval) * at least 1 measurable site of disease according to the revised response criteria for malignant lymphoma (that is, the site of disease must be greater than 1.5 centimeter \[cm\] in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions) * have documented failure to achieve at least partial response (pr) with, or documented disease progression after, the most recent anti-mcl treatment regimen * eastern cooperative oncology group performance status score of 0 or 1 exclusion criteria: * prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 4 weeks of the first dose of study drug * prior treatment with ibrutinib or other bruton's tyrosine kinase (btk) inhibitors * more than 5 prior lines of therapy for mcl (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6-month treatment-free interval) * known central nervous system (cns) lymphoma * woman who is pregnant, breast-feeding, or planning to become pregnant within 1 month after the last dose of study drug or is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug

Keywords: ibrutinib imbruvica pci-32765 jnj-54179060 lymphoma, mantle-cell