Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
NCT ID: NCT01980628
Last Updated: 2019-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2013-12-31
2017-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ibrutinib
ibrutinib capsules: 560 mg once daily
ibrutinib
Interventions
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ibrutinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and women ≥18 years of age
* ECOG performance status of ≤2
* ≥1 measurable lesion site on CT scan (\>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead. (Subjects with spleen-only disease are considered as not having measurable disease.)
* Life expectancy of \>3 months, in the opinion of the investigator
Exclusion Criteria
* History of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥2 years
* History of allogeneic stem-cell (or other organ) transplantation
* Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug
* Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug
* Concurrent use of warfarin or other vitamin K antagonists
* Concurrent use of a strong CYP3A inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication.
* Recent infection requiring IV anti-infective treatment that was completed ≤14 days before the first dose of study drug
* Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE Grade 0 or 1, or to the levels dictated in the eligibility criteria with the exception of alopecia
* Inadequate organ function as defined on laboratory tests
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Isaiah Dimery, MD
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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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
Site Reference ID/Investigator # 407
New York, New York, United States
Site Reference ID/Investigator# 220
Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 348
Seattle, Washington, United States
Site Reference ID/Investigator# 560
Ghent, Oost-vlaanderen, Belgium
Site Reference ID/Investigator# 142
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Site Reference ID/Investigator# 737
Rouen, Haute-normandie, France
Site Reference ID/Investigator# 750
Lille, Hauts-de-France, France
Site Reference ID/Investigator# 749
La Roche-sur-Yon, Pays de la Loire Region, France
Site Reference ID/Investigator# 736
Nantes, Pays de la Loire Region, France
Site Reference ID/Investigator# 742
Rennes, , France
Site Reference ID/Investigator# 735
Paris, Île-de-France Region, France
Site Reference ID/Investigator# 669
Mainz, Rhineland-Palatinate, Germany
Site Reference ID/Investigator# 030
Manchester, England, United Kingdom
Site Reference ID/Investigator# 814
Oxford, England, United Kingdom
Site Reference ID/Investigator# 368
Plymouth, England, United Kingdom
Countries
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References
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Noy A, de Vos S, Coleman M, Martin P, Flowers CR, Thieblemont C, Morschhauser F, Collins GP, Ma S, Peles S, Smith SD, Barrientos JC, Chong E, Wu S, Cheung LW, Kwei K, Hauns B, Arango-Hisijara I, Chen R. Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis. Blood Adv. 2020 Nov 24;4(22):5773-5784. doi: 10.1182/bloodadvances.2020003121.
Noy A, de Vos S, Thieblemont C, Martin P, Flowers CR, Morschhauser F, Collins GP, Ma S, Coleman M, Peles S, Smith S, Barrientos JC, Smith A, Munneke B, Dimery I, Beaupre DM, Chen R. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017 Apr 20;129(16):2224-2232. doi: 10.1182/blood-2016-10-747345. Epub 2017 Feb 6.
Other Identifiers
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PCYC-1121-CA
Identifier Type: -
Identifier Source: org_study_id
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