Overview

This trial is active, not recruiting.

Conditions chronic lymphocytic leukemia with 17p deletion, small lymphocytic lymphoma with 17p deletion
Treatment pci-32765
Phase phase 2
Target BTK
Sponsor Pharmacyclics
Collaborator Janssen Research & Development, LLC
Start date January 2013
End date January 2016
Trial size 111 participants
Trial identifier NCT01744691, 2012-004476-19, PCYC-1117-CA

Summary

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 Lymphocytic Lymphoma with 17p Deletion

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
pci-32765
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.

Primary Outcomes

Measure
Overall Response Rate
time frame: 6 -12 months after last patient enrolled

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Key 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 PCI-32765

Additional Information

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 Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
Description This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of PCI-32765 in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive PCI-32765 until disease progression or unacceptable toxicity occurs.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Pharmacyclics.