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Trial record 1 of 1 for:    NCT01744691
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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

This study has been completed.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT01744691
First received: December 3, 2012
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Chronic Lymphocytic Leukemia With 17p Deletion
Small Lymphocytic Lymphoma With 17p Deletion
Drug: Ibrutinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Pharmacyclics LLC.:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 145
Study Start Date: January 2013
Study Completion Date: April 2016
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744691

  Show 55 Study Locations
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Investigators
Study Director: Alvina Chu, MD Pharmacyclics LLC.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT01744691     History of Changes
Other Study ID Numbers: PCYC-1117-CA
2012-004476-19 ( EudraCT Number )
Study First Received: December 3, 2012
Results First Received: May 21, 2015
Last Updated: January 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Pharmacyclics LLC.:
CLL
SLL

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on March 24, 2017