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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Pharmacyclics LLC.

Current Primary Outcome: ORR (Overall Response Rate) [ Time Frame: Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 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 comittee (IRC).


Original Primary Outcome: To evaluate efficacy using the Overall Response Rate (ORR) in subjects with MZL [ Time Frame: 3 years ]

Current Secondary Outcome: DOR (Duration of Response) [ Time Frame: Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 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.


Original Secondary Outcome:

  • To evaluate efficacy parameter such as duration of response (DOR) to ibrutinib in subjects with MZL [ Time Frame: 3 years ]
  • Frequency, severity, and relatedness of adverse events [ Time Frame: 3 years ]
  • To determine the plasma pharmacokinetics of ibrutinib and the metabolite, PCI-45227 [ Time Frame: 3 years ]
  • To evaluate efficacy parameter such as progression-free survival (PFS) to ibrutinib in subjects with MZL [ Time Frame: 3 years ]
  • To evaluate efficacy parameter such as overall survival (OS) to ibrutinib in subjects with MZL [ Time Frame: 3 years ]


Information By: Pharmacyclics LLC.

Dates:
Date Received: October 29, 2013
Date Started: December 2013
Date Completion: February 2018
Last Updated: December 20, 2016
Last Verified: December 2016