Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).
Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
ORR (Overall Response Rate)
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). Per Cheson: CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.
Time frame: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.
DOR (Duration of Response)
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.
Time frame: Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.
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Site Reference ID/Investigator# 837
Tucson, Arizona, United States
Site Reference ID/Investigator# 047
Duarte, California, United States
Site Reference ID/Investigator# 377
Santa Monica, California, United States
Site Reference ID/Investigator# 763
West Palm Beach, Florida, United States
Site Reference ID/Investigator# 033
Atlanta, Georgia, United States
Site Reference ID/Investigator# 370
Chicago, Illinois, United States
Site Reference ID/Investigator# 195
Detroit, Michigan, United States
Site Reference ID/Investigator# 350
New Hyde Park, New York, United States
Site Reference ID/Investigator# 745
New York, New York, United States
Site Reference ID/Investigator # 200
New York, New York, United States
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