Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma

NCT ID: NCT02169180

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-12-31

Brief 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).

Detailed Description

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.

Conditions

Lymphoma, Mantle-cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ibrutinib

Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response \[CR\]), unacceptable toxicity, or end of treatment, whichever occurs first.

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response \[CR\]), unacceptable toxicity, or end of treatment, whichever occurs first.

Interventions

Ibrutinib

Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response \[CR\]), unacceptable toxicity, or end of treatment, whichever occurs first.

Intervention Type: DRUG

Other Intervention Names

IMBRUVICA; PCI-32765; JNJ-54179060

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Fukuoka, , Japan

Isehara, , Japan

Kobe, , Japan

Kyoto, , Japan

Nagoya, , Japan

Osaka, , Japan

Sendai, , Japan

Tokyo, , Japan

Countries

Japan

References

Maruyama D, Nagai H, Fukuhara N, Kitano T, Ishikawa T, Shibayama H, Choi I, Hatake K, Uchida T, Nishikori M, Kinoshita T, Matsuno Y, Nishikawa T, Takahara S, Tobinai K. Efficacy and safety of ibrutinib in Japanese patients with relapsed or refractory mantle cell lymphoma. Cancer Sci. 2016 Dec;107(12):1785-1790. doi: 10.1111/cas.13076. Epub 2016 Nov 25.

Reference Type: DERIVED

PMID: 27616553 (View on PubMed)

Other Identifiers

PCI-32765MCL2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR104615

Identifier Type: -

Identifier Source: org_study_id