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 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.

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)

Conditions
-----------------
Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion

Intervention / Treatment
-----------------
* Drug: Ibrutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
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 ibrutinib

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibrutinib<br>All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily. | Drug: Ibrutinib<br>* All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | 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. | The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Number of participants who had experienced at least one treatment emergent AE | From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, SLL