Clinical Trial: A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymph
Brief Summary: An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
Detailed Summary: This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
Sponsor: Pharmacyclics LLC.
Current Primary Outcome: Overall Response Rate [ Time Frame: The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months ]
Original Primary Outcome: Overall Response Rate [ Time Frame: 6 -12 months after last patient enrolled ]
Current Secondary Outcome: Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure ]
Original Secondary Outcome:
- Duration of Response [ Time Frame: 18 months after last patient enrolled ]
- Safety Parameters: Number and type of adverse events [ Time Frame: 18 months after last patient enrolled ]
Information By: Pharmacyclics LLC.
Dates:
Date Received: December 3, 2012
Date Started: January 2013
Date Completion:
Last Updated: January 9, 2017
Last Verified: January 2017