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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pharmacyclics LLC.
- Enrollment
- 145
- Primary Endpoint
- Overall Response Rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
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
Arms & Interventions
ibrutinib
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
Intervention: Ibrutinib (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)