A Phase II Study of PCI-32765 for Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Need Therapy and Are Older Than 65 or Have a 17p Deletion
CLL/SLL is a malignancy of B cells that predominantly affects the elderly population.
Diagnosis is typically made in adults over the age of 50 and more than half of the people
with CLL/SLL are over the age of 70. Elderly patients in particular have other comorbidities
that limit the tolerability of standard CLL/SLL chemoimmunotherapy regimens and they often
have inferior response to these particular regimens. In addition, those patients with a 17p
deletion also have inferior outcomes due to rapid progression of disease as well as
refractoriness to standard treatment regimens.
It is still unclear what leads to the development of CLL/SLL. However, recent studies
indicated that B cell receptor (BCR) signaling is an important contributor to the disease
and could be a target for therapy. Bruton's Tyrosine Kinase (Btk) is an enzyme required for
PCI-32765 is a potent and selective inhibitor of Bruton Tyrosine Kinase (Btk). In vitro
lymphoma models have demonstrated that PCI-32765 inhibits Btk. Inhibition of Btk blocks
downstream BCR signaling pathways and thus prevents B cell proliferation. A phase 1 study of
PCI-32765 shows activity in multiple lymphomas including CLL/SLL.
This study will investigate the efficacy of PCI-32765 for patients with CLL/SLL in patients
that are older than 65 who are in need of therapy. In addition, those patients with a 17p
deletion will also be treated as an early intervention as overall survival is poor in this
patient cohort. This protocol is intended both for patients who have been untreated and
those who have undergone other therapies.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the overall response rate (ORR) of PCI 32765 at 420 mg in CLL/ SLL after 6 cycles.
Mohammed Z Farooqui, D.O.
National Heart, Lung, and Blood Institute (NHLBI)
United States: Federal Government
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