search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia With 17p Deletion focused on measuring CLL, SLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ibrutinib

Arm Description

All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (AEs)
Number of participants who had experienced at least one treatment emergent AE

Full Information

First Posted
December 3, 2012
Last Updated
January 9, 2017
Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01744691
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion
Keywords
CLL, SLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibrutinib
Arm Type
Experimental
Arm Description
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Description
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (AEs)
Description
Number of participants who had experienced at least one treatment emergent AE
Time Frame
From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvina Chu, MD
Organizational Affiliation
Pharmacyclics LLC.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Duarte
State/Province
California
Country
United States
City
Greenbrae
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
New Hyde Park
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Goldsboro
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Toldedo
State/Province
Ohio
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Adelaide
Country
Australia
City
Coburg
Country
Australia
City
East Melbourne
Country
Australia
City
Fremantle
Country
Australia
City
Antwerp
Country
Belgium
City
Brugge
Country
Belgium
City
Brussels
Country
Belgium
City
Gent
Country
Belgium
City
Kortrijk
Country
Belgium
City
Leuven
Country
Belgium
City
Roeselare
Country
Belgium
City
Edmonton
State/Province
Alberta
Country
Canada
City
Cologne
Country
Germany
City
Dresden
Country
Germany
City
Heidelberg
Country
Germany
City
Munich
Country
Germany
City
Ulm
Country
Germany
City
Auckland
Country
New Zealand
City
Christchurch
Country
New Zealand
City
Goteborg
Country
Sweden
City
Lund
Country
Sweden
City
Stockholm
Country
Sweden
City
Ankara
Country
Turkey
City
Gaziantep
Country
Turkey
City
Istanbul
Country
Turkey
City
Izmir
Country
Turkey
City
Kayseri
Country
Turkey
City
Bournemouth
Country
United Kingdom
City
Glasgow
Country
United Kingdom
City
Leeds
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Newcastle upon Tyne
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27637985
Citation
O'Brien S, Jones JA, Coutre SE, Mato AR, Hillmen P, Tam C, Osterborg A, Siddiqi T, Thirman MJ, Furman RR, Ilhan O, Keating MJ, Call TG, Brown JR, Stevens-Brogan M, Li Y, Clow F, James DF, Chu AD, Hallek M, Stilgenbauer S. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016 Oct;17(10):1409-1418. doi: 10.1016/S1470-2045(16)30212-1. Epub 2016 Sep 13.
Results Reference
derived
Links:
URL
http://www.pharmacyclics.com
Description
www.pharmacyclics.com

Learn more about this 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

We'll reach out to this number within 24 hrs