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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.
 
ClinicalTrials.gov Identifier: NCT01744691
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : June 9, 2015
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 7, 2012
Results First Submitted Date  ICMJE May 21, 2015
Results First Posted Date  ICMJE June 9, 2015
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
Overall Response Rate [ Time Frame: 6 -12 months after last patient enrolled ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2012)
  • Duration of Response [ Time Frame: 18 months after last patient enrolled ]
  • Safety Parameters: Number and type of adverse events [ Time Frame: 18 months after last patient enrolled ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: December 6, 2012)
  • Progression-free survival [ Time Frame: 18 months after last patient enrolled ]
  • Overall survival [ Time Frame: 18 months after last patient enrolled ]
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia With 17p Deletion
  • Small Lymphocytic Lymphoma With 17p Deletion
Intervention  ICMJE Drug: Ibrutinib
All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
Study Arms  ICMJE Experimental: ibrutinib
All subjects will receive ibrutnib 420 mg (3 x 140-mg capsules) orally once daily.
Intervention: Drug: Ibrutinib
Publications * O'Brien S, Jones JA, Coutre SE, Mato AR, Hillmen P, Tam C, Österborg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2015)
145
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2012)
111
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Germany,   New Zealand,   Sweden,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01744691
Other Study ID Numbers  ICMJE PCYC-1117-CA
2012-004476-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pharmacyclics LLC.
Study Sponsor  ICMJE Pharmacyclics LLC.
Collaborators  ICMJE Janssen Research & Development, LLC
Investigators  ICMJE
Study Director: Alvina Chu, MD Pharmacyclics LLC.
PRS Account Pharmacyclics LLC.
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP