A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)
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|ClinicalTrials.gov Identifier: NCT04062448|
Recruitment Status : Not yet recruiting
First Posted : August 20, 2019
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom Macroglobulinemia||Drug: Ibrutinib Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Combination With Rituximab, in Japanese Patients With Waldenstrom's Macroglobulinemia (WM)|
|Estimated Study Start Date :||September 11, 2019|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Ibrutinib + Rituximab
Participants will receive ibrutinib 420 milligram (mg) orally, once daily, from Day 1 of Week 1 until disease progression or unacceptable toxicity in combination with rituximab 375 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 of Weeks 1 to 4 and Weeks 17 to 20.
Ibrutinib 420 mg will be administered orally.
Other Name: PCI-32765
Rituximab 375 mg/m^2 will be administered intravenously.
- Overall Response Rate (ORR) - Assessed by Independent Review Committee (IRC) [ Time Frame: Up to 3.7 years ]The ORR is defined as the percentage of participants with complete response (CR), very good partial response (VGPR) or partial response (PR) by IRC assessment.
- Progression Free Survival (PFS) [ Time Frame: Up to 3.7 years ]PFS is defined as duration from the date of initial dose of ibrutinib to the date of disease progression or death, whichever occurs first.
- Pharmacokinetics (PK) of Ibrutinib and its Metabolite PCI-45227 [ Time Frame: Day 1 of Week 4 ]Plasma concentration of ibrutinib and its metabolite PCI-45227 will be reported.
- Prognostic Biomarkers Relative to Disease and/or Treatment [ Time Frame: Predose (Week 1) ]Blood samples will be collected for biomarker analysis that may include myeloid differentiation primary response gene 88 (MYD88), and C-X-C chemokine receptor type 4 (CXCR-4), thought to be prognostic of disease and/or treatment.
- Number of Participants with Adverse Events [ Time Frame: Up to 3.7 years ]An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062448
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|National Cancer Center Hospital||Not yet recruiting|
|Chuo-ku, Japan, 104-0045|
|Kameda Medical Center||Not yet recruiting|
|Kamogawa City, Japan, 296-8602|
|National Hospital Organization Kumamoto Medical Center||Not yet recruiting|
|Kumamoto-City, Japan, 860-0008|
|Matsuyama Red Cross Hospital||Not yet recruiting|
|Matsuyama-City, Japan, 790-8524|
|Nagoya City University Hospital||Not yet recruiting|
|Nagoya-City, Japan, 467-8602|
|Osaka City University Hospital||Not yet recruiting|
|Osaka-City, Japan, 545-8586|
|Osaka University Hospital||Not yet recruiting|
|Suita-City, Japan, 565-0871|
|NHO Disaster Medical Center||Not yet recruiting|
|Tachikawa, Japan, 190-0014|
|University of Tsukuba Hospital||Not yet recruiting|
|Tsukuba-City, Japan, 305-8576|
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|