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

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia With 17p Deletion; Small Lymphocytic Lymphoma With 17p Deletion
• Interventions: Drug: Ibrutinib

• Registration Number: NCT01744691
• Lead Sponsor: Pharmacyclics LLC.

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 Description

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.

Study Timeline

• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-07
• Study Start: 2013-01
• Primary Completion: 2014-06
• Results First Submitted: 2015-05-21
• Results First Submitted QC: 2015-05-21
• Results First Posted: 2015-06-09
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Documentation of del (17p13.1)
• Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
• Measurable nodal disease by computed tomography (CT)

Key

Exclusion Criteria

• History or current evidence of Richter's transformation or prolymphocytic leukemia
• Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
• Prior exposure to ibrutinib

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ibrutinib	Ibrutinib	All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (AEs)	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