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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: October 7, 2013
Last verified: October 2013

December 3, 2012
October 7, 2013
January 2013
January 2016   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: 6 -12 months after last patient enrolled ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01744691 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
Same as current
 
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
111
March 2016
January 2016   (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
October 2013

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