A Multicenter Phase 2 Study of PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01744691
First received: December 3, 2012
Last updated: May 21, 2015
Last verified: May 2015

December 3, 2012
May 21, 2015
January 2013
June 2014   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: The median time on study for all treated participants is 11.5 (range 0.5 - 16.6) months ] [ Designated as safety issue: No ]
The primary objective of this study is to evaluate the efficacy of PCI-32765 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.
Overall Response Rate [ Time Frame: 6 -12 months after last patient enrolled ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01744691 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Number of participants who had experienced at least one treatment emergent AE
  • Duration of Response [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: No ]
  • Safety Parameters: Number and type of adverse events [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: Yes ]
Not Provided
  • Progression-free survival [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 18 months after last patient enrolled ] [ Designated as safety issue: No ]
 
A Multicenter Phase 2 Study of PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
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 PCI-32765 (Ibrutinib) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion

This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of PCI-32765 in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive PCI-32765 until disease progression or unacceptable toxicity occurs.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Lymphocytic Leukemia With 17p Deletion
  • Small Lymphocytic Lymphoma With 17p Deletion
Drug: PCI-32765
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
Experimental: PCI-32765
All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.
Intervention: Drug: PCI-32765
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
145
March 2016
June 2014   (final data collection date for primary outcome measure)

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 PCI-32765
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01744691
PCYC-1117-CA, 2012-004476-19
No
Pharmacyclics
Pharmacyclics
Janssen Research & Development, LLC
Study Director: Alvina Chu, MD Pharmacyclics
Pharmacyclics
May 2015

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