Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
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|ClinicalTrials.gov Identifier: NCT01980628|
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : February 10, 2017
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone Lymphoma B-cell Lymphoma||Drug: ibrutinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||October 2, 2017|
ibrutinib capsules: 560 mg once daily
Other Name: PCI-32765
- ORR (Overall Response Rate) [ Time Frame: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. ]
ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC).
CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
- DOR (Duration of Response) [ Time Frame: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months. ]The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.
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): NCT01980628
|Study Director:||Isaiah Dimery, MD||Pharmacyclics LLC.|