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 |
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
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.
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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