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

January 9, 2017 updated by: Pharmacyclics LLC.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Coburg, Australia
      • East Melbourne, Australia
      • Fremantle, Australia
  • Belgium
      • Antwerp, Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Kortrijk, Belgium
      • Leuven, Belgium
      • Roeselare, Belgium
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
  • Germany
      • Cologne, Germany
      • Dresden, Germany
      • Heidelberg, Germany
      • Munich, Germany
      • Ulm, Germany
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
  • Sweden
      • Goteborg, Sweden
      • Lund, Sweden
      • Stockholm, Sweden
  • Turkey
      • 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
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Duarte, California, United States
      • Greenbrae, California, United States
      • La Jolla, California, United States
      • Stanford, California, United States
    • Florida
      • Tampa, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Hackensack, New Jersey, United States
    • New York
      • New Hyde Park, New York, United States
      • New York, New York, United States
    • North Carolina
      • Goldsboro, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Toldedo, Ohio, United States
    • Texas
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Collaborators

Janssen Research & Development, LLC

Investigators

  • Study Director: Alvina Chu, MD, Pharmacyclics LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 7, 2012

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-1117-CA
  • 2012-004476-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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