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 ]

The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.


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 ]

Number of participants who had experienced at least one treatment emergent AE


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