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

NCT02169180 | Completed Phase 2

• 2 other identifiers: CR104615PCI-32765MCL2002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 8

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).

Conditions

Lymphoma, Mantle-cell

Keywords

Ibrutinib; IMBRUVICA; PCI-32765; JNJ-54179060; Lymphoma, Mantle-cell

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Response

  Overall response is defined as achievement of complete response (CR) or partial response (PR), as assessed by the Independent Review Committee (IRC), based on the Revised Response Criteria for Malignant Lymphoma. CR is: a) disappearance of all detectable disease symptoms and signs; b) lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size; c) negative positron emission tomography (PET) scan; d) normal sized spleen or liver if enlarged before therapy; d) bone marrow infiltrate must be cleared if would have been involved before treatment; e) no new sites of disease. PR is: a) greater than 50 percent decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, splenic and hepatic nodules; b) no increase in the size of other nodes, liver, or spleen, c) no measurable disease in other organs; d) no new sites of disease; e) 1 PET-positive site of disease (required for the CT+PET assessment of PR).

  Up to 2 years after last participant enrolled

Secondary Outcomes (8)

• Duration of Response

  Up to 2 years after last participant enrolled

• Time to Response

  Up to 2 years after last participant enrolled

• Overall Survival (OS)

  Up to 2 years after last participant enrolled

• Progression-free Survival (PFS)

  Up to 2 years after last participant enrolled

• Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  Day 1 up to 30 days after last dose administration

Study Arms (1)

Ibrutinib

EXPERIMENTAL

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.

Drug: Ibrutinib

Interventions

Ibrutinib 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.

Also known as: IMBRUVICA, PCI-32765, JNJ-54179060

Ibrutinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (8)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Isehara, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Sendai, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 27616553 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

JP (8)