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 (RESONATEā¢-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
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
6 -12 months after last patient enrolled
No
Alvina Chu, MD
Study Director
Pharmacyclics
Australia: Department of Health and Ageing Therapeutic Goods Administration
PCYC-1117
NCT01744691
January 2013
March 2016
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |