Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally
 bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been
 treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or
 were refractory to such therapy or discontinued such therapy due to toxicity.
Inclusion Criteria:

 1. ≥ 18 years of age.

 2. Diagnosis of CLL or SLL.

 3. Received at least one prior anti-cancer therapy for CLL or SLL.

 4. Previous exposure to BTKi and meet at least one of the criteria below:

 1. Progressive disease (PD) while receiving or within 6 months after completing BTKi
 therapy.

 2. Discontinued a BTKi therapy due to BTKi treatment- related intolerance.

 5. Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.

 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

 7. Resolution of toxicities due to prior BTKi therapy to acceptable level.

 8. Willingness of male and female patients to use medically acceptable methods of birth
 control.

 9. Willing and able to participate in all required study evaluations and procedures.

 Exclusion Criteria:

 1. Richter's transformation or prolymphocytic leukemia

 2. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia

 3. Received prior transplant

 4. Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K)
 inhibitor

 5. Known central nervous system involvement by CLL/SLL