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: Drug: ibrutinib

• 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.

Study Timeline

• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Study Start: 2013-12
• Primary Completion: 2016-07
• Results First Submitted: 2016-12-20
• Results First Submitted QC: 2016-12-20
• Results First Posted: 2017-02-10
• Study Completion: 2017-10-02
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-16

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

Group	Intervention	Description
ibrutinib	ibrutinib	ibrutinib capsules: 560 mg once daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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# 030; 🇬🇧 Manchester, England, United Kingdom

Site Reference ID/Investigator# 560; 🇧🇪 Ghent, Oost-vlaanderen, Belgium

Site Reference ID/Investigator# 814; 🇬🇧 Oxford, England, United Kingdom

Site Reference ID/Investigator# 368; 🇬🇧 Plymouth, England, United Kingdom

Site Reference ID/Investigator# 195; 🇺🇸 Detroit, Michigan, United States

Site Reference ID/Investigator# 348; 🇺🇸 Seattle, Washington, United States

Site Reference ID/Investigator# 370; 🇺🇸 Chicago, Illinois, United States

Site Reference ID/Investigator# 837; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 745; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 377; 🇺🇸 Santa Monica, California, United States

Site Reference ID/Investigator# 047; 🇺🇸 Duarte, California, United States

Site Reference ID/Investigator # 407; 🇺🇸 New York, New York, 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 # 200; 🇺🇸 New York, New York, United States

Site Reference ID/Investigator# 350; 🇺🇸 New Hyde Park, New York, United States

Site Reference ID/Investigator# 220; 🇺🇸 Hershey, Pennsylvania, United States

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# 749; 🇫🇷 La Roche-sur-Yon Cedex 9, PAYS DE LA Loire, France

Site Reference ID/Investigator# 742; 🇫🇷 Rennes cedex 9, France

Site Reference ID/Investigator# 669; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Site Reference ID/Investigator# 750; 🇫🇷 Lille Cedex, NORD Pas-de-calais, France

Site Reference ID/Investigator# 142; 🇫🇷 Pierre Bénite Cedex, Rhone-alpes, France

Site Reference ID/Investigator# 736; 🇫🇷 Nantes cedex 1, PAYS DE LA Loire, France