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Trial record 1 of 5 for:    Resonate 2
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744691
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : June 9, 2015
Last Update Posted : February 27, 2017
Janssen Research & Development, LLC
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia With 17p Deletion Small Lymphocytic Lymphoma With 17p Deletion Drug: Ibrutinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: ibrutinib
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
Drug: Ibrutinib
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744691

Hide Hide 55 study locations
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United States, Arizona
Phoenix, Arizona, United States
United States, California
Duarte, California, United States
Greenbrae, California, United States
La Jolla, California, United States
Stanford, California, United States
United States, Florida
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, New York
New Hyde Park, New York, United States
New York, New York, United States
United States, North Carolina
Goldsboro, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
Toldedo, Ohio, United States
United States, Texas
Houston, Texas, United States
Adelaide, Australia
Coburg, Australia
East Melbourne, Australia
Fremantle, Australia
Antwerp, Belgium
Brugge, Belgium
Brussels, Belgium
Gent, Belgium
Kortrijk, Belgium
Leuven, Belgium
Roeselare, Belgium
Canada, Alberta
Edmonton, Alberta, Canada
Cologne, Germany
Dresden, Germany
Heidelberg, Germany
Munich, Germany
Ulm, Germany
New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Goteborg, Sweden
Lund, Sweden
Stockholm, Sweden
Ankara, Turkey
Gaziantep, Turkey
Istanbul, Turkey
Izmir, Turkey
Kayseri, Turkey
United Kingdom
Bournemouth, United Kingdom
Glasgow, United Kingdom
Leeds, United Kingdom
Leicester, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle upon Tyne, United Kingdom
Oxford, United Kingdom
Plymouth, United Kingdom
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
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Study Director: Alvina Chu, MD Pharmacyclics LLC.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pharmacyclics LLC. Identifier: NCT01744691    
Other Study ID Numbers: PCYC-1117-CA
2012-004476-19 ( EudraCT Number )
First Posted: December 7, 2012    Key Record Dates
Results First Posted: June 9, 2015
Last Update Posted: February 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pharmacyclics LLC.:
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell