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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

6 -12 months after last patient enrolled

Safety Issue:

No

Principal Investigator

Alvina Chu, MD

Investigator Role:

Study Director

Investigator Affiliation:

Pharmacyclics

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

PCYC-1117

NCT ID:

NCT01744691

Start Date:

January 2013

Completion Date:

March 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia With 17p Deletion
  • Small Lymphocytic Lymphoma With 17p Deletion
  • CLL
  • SLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096