A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom's Macroglobulinemia (WM)
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|ClinicalTrials.gov Identifier: NCT04042376|
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : December 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Waldenstrom Macroglobulinemia||Drug: Ibrutinib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Multicenter, Phase 4 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) in Chinese Subjects With Relapse or Refractory Waldenström's Macroglobulinemia|
|Actual Study Start Date :||December 18, 2019|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||March 29, 2024|
Experimental: Ibrutinib 420 milligram (mg)
Participants will receive ibrutinib 420 mg once daily, continuously starting at Day 1 of Week 1 until disease progression or unacceptable toxicity, whichever occurs first.
Ibrutinib will be administered orally, once daily, at a dose of 420 mg (140 mg*3 capsules taken together at one time).
- Overall Response Rate (ORR) [ Time Frame: Up to 4 years ]ORR is defined as the percentage of participants who achieve partial response (PR) or better per the modified Consensus Response Criteria from the 6th International Workshop on Waldenstrom Macroglobulinemia (IWWM) (NCCN 2019) as assessed by the investigator.
- Percentage of Participants Achieving Clinical Response Rate (CRR) [ Time Frame: Up to 4 years ]CRR is defined as the percentage of participants who achieve minor response (MR) or better according to the modified 4th IWWM (NCCN 2019) criteria as assessed by the investigator.
- Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response [ Time Frame: Up to 4 years ]VGPR or better rate is defined as the percentage of participants who achieve VGPR or better according to the modified 4th IWWM (NCCN 2019) criteria as assessed by the investigator.
- Duration of Response (DOR) [ Time Frame: Up to 4 years ]DOR is defined as duration from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease or death for responders (PR or better) as assessed by the investigator.
- Time to Response (TTR) [ Time Frame: Up to 4 years ]TTR is defined as the time from the date of first dose to the date of initial documentation of a response (PR or better).
- Progression Free Survival (PFS) [ Time Frame: Up to 4 years ]PFS is defined as duration from the date of first dose to the date of disease progression or death, whichever is first reported, assessed according to the modified 6th IWWM (NCCN 2019) criteria.
- Overall Survival (OS) [ Time Frame: Up to 4 years ]OS is defined as the time from the date of first dose to the date of the participant's death from any cause.
- Trough Plasma Concentration (Ctrough) of Ibrutinib [ Time Frame: Day 1 of Weeks 1, 5 and 9 ]Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 4 years ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042376
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|The First Hospital of Jilin University||Recruiting|
|Changchun, China, 130021|
|Peking Union Medical College Hospital||Withdrawn|
|Dongcheng, China, 100032|
|Fujian Meidical University Union Hospital||Withdrawn|
|Fuzhou, China, 350001|
|Guangdong Provincial People's Hospital||Withdrawn|
|Guangzhou, China, 510100|
|First affiliated Hospital of Zhejiang University||Recruiting|
|Hangzhou, China, 310003|
|The People's Hospital of Jiangsu Province||Withdrawn|
|Nanjing, China, 210029|
|Institute of Hematology & Blood Diseases Hospital||Recruiting|
|Tianjin, China, 300320|
|Wuhan Union Hospital||Recruiting|
|Wuhan, China, 430022|
|The Second Affiliated Hospital of Xi'an Jiaotong University||Recruiting|
|Xi'an, China, 710004|
|Henan Cancer Hospital||Recruiting|
|Zhengzhou, China, 450008|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|