The purpose of this study is to evaluate overall response rate (ORR) by Independent Review Committee (IRC) assessment, when combined with rituximab in Japanese participants with treatment naïve or relapsed/refractory Waldenstrom's Macroglobulinemia (WM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Kameda Medical Center
Chiba, Japan
National Cancer Center Hospital
Chūōku, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Matsuyama Red Cross Hospital
Matsuyama, Japan
Overall Response Rate (ORR) According to the Modified Sixth International Workshop on Waldenstrom's Macroglobulinemia (IWWM) Criteria
ORR is defined as the percentage of participants achieving a best overall response of confirmed complete response (CR), very good partial response (VGPR) or partial response (PR) according to the modified sixth IWWM criteria (National Comprehensive Cancer Network \[NCCN\] version 2, 2019), as assessed by the Independent Review Committee (IRC). CR: Immunoglobulin M (IgM) in normal range, disappearance of monoclonal protein by immunofixation, no histologic evidence of bone marrow involvement, resolution of any adenopathy/organomegaly (if present at baseline) along with no signs or symptoms attributable to Waldenstrom's Macroglobulinemia (WM); VGPR and PR: greater than or equal to (\>=) 90 percent (%) (for VGPR) and \>=50% (for PR) reduction of serum IgM, decrease in adenopathy/organomegaly (if present at baseline) on physical examination or computerized tomography (CT) scan, no new symptoms or signs of active disease.
Time frame: Up to 1 year 11 months
Progression Free Survival (PFS) Assessed by Independent Review Committee
PFS was defined as duration from the date of initial dose of ibrutinib to the date of first documented evidence of disease progression or death, whichever occurred first regardless of the use of subsequent antineoplastic therapy prior to documented disease progression or death. Kaplan-Meier method was used for the analysis.
Time frame: From the date of initial dose up to 3 years and 5 months
Plasma Concentrations of Ibrutinib
Plasma concentrations of ibrutinib were reported.
Time frame: Day 1 of Week 4: Predose, 1 hour, 2 hours, 4 hours, and 6 hours postdose
Plasma Concentrations of Metabolite PCI-45227
Plasma concentrations of metabolite PCI-45227 were reported.
Time frame: Day 1 of Week 4: Predose, 1 hour, 2 hours, 4 hours, and 6 hours postdose
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Nagoya City University Hospital
Nagoya, Japan
Osaka Metropolitan University Hospital
Osaka, Japan
Osaka University Hospital
Suita, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Japan
University of Tsukuba Hospital
Tsukuba, Japan
Number of Participants With Myeloid Differentiation Primary Response Gene 88 (MYD88) Biomarker Mutation
Number of participants with MYD88 biomarker mutations were reported. MYD88 was assessed using next generation sequencing to detect the somatic mutations in the bone marrow aspiration samples collected during the study.
Time frame: Day 1 of Week 1
Number of Participants With C-X-C Chemokine Receptor Type 4 (CXCR-4) Biomarker Mutations
Number of participants with CXCR-4 biomarker mutations were reported. CXCR-4 was assessed using next generation sequencing to detect the somatic mutations in the bone marrow aspiration samples collected during the study.
Time frame: Day 1 of Week 1
Number of Participants With Treatment- Emergent Adverse Events (TEAEs)
An adverse event was defined as any untoward medical event that occurred in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as any AE that occurred at or after the initial administration of study intervention through the day of last dose plus 30 days.
Time frame: From first dose of study drug up to 30 days post last dose of study drug (that is, up to 40.6 months)