Spots Global Cancer Trial Database for Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
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Trial Identification
Brief Title: Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
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 ID: NCT01980628
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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# 737, Rouen Cedex 1, Haute-normandie, France
Site Reference ID/Investigator# 735, Paris Cedex 10, Ile-de-france, France
Site Reference ID/Investigator# 750, Lille Cedex, NORD Pas-de-calais, France
Site Reference ID/Investigator# 749, La Roche-sur-Yon Cedex 9, PAYS DE LA Loire, France
Site Reference ID/Investigator# 736, Nantes cedex 1, PAYS DE LA Loire, France
Site Reference ID/Investigator# 142, Pierre Bénite Cedex, Rhone-alpes, France
Site Reference ID/Investigator# 742, Rennes cedex 9, , France
Site Reference ID/Investigator# 669, Mainz, Rheinland-Pfalz, 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
Contact Details
Name: Isaiah Dimery, MD
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR
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