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Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

Phase 2
Completed
Conditions
B-cell Lymphoma
Marginal Zone Lymphoma
Interventions
Registration Number
NCT01980628
Lead Sponsor
Pharmacyclics LLC.
Brief Summary

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).

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ibrutinibibrutinibibrutinib capsules: 560 mg once daily
Primary Outcome Measures
NameTimeMethod
ORR (Overall Response Rate)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).

Per Cheson:

CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.

Secondary Outcome Measures
NameTimeMethod
DOR (Duration of Response)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.

Trial Locations

Locations (25)

Site Reference ID/Investigator# 837

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Tucson, Arizona, United States

Site Reference ID/Investigator# 047

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Duarte, California, United States

Site Reference ID/Investigator# 377

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Santa Monica, California, United States

Site Reference ID/Investigator# 763

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West Palm Beach, Florida, United States

Site Reference ID/Investigator# 033

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Atlanta, Georgia, United States

Site Reference ID/Investigator# 370

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Chicago, Illinois, United States

Site Reference ID/Investigator# 195

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Detroit, Michigan, United States

Site Reference ID/Investigator# 350

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New Hyde Park, New York, United States

Site Reference ID/Investigator# 745

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New York, New York, United States

Site Reference ID/Investigator # 200

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New York, New York, United States

Scroll for more (15 remaining)
Site Reference ID/Investigator# 837
🇺🇸Tucson, Arizona, United States

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