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



Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2013
End Date:March 2016

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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)

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.

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
We found this trial at
19
sites
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New Hyde Park, NY
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Adelaide,
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Ann Arbor, MI
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Boston, MA
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Chicago, IL
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Columbus, OH
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Duarte, CA
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Goldsboro, North Carolina 27534
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Goldsboro, NC
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Greenbrae, CA
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Hackensack, NJ
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Houston, TX
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La Jolla, CA
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New York, NY
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Phoenix, AZ
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Rochester, MN
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St. Louis, MO
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Stanford, CA
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Tampa, FL
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Toldedo, OH
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