Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma

Inclusion Criteria

• ≥ 18 years of age.
• Diagnosis of CLL or SLL.
• Received at least one prior anti-cancer therapy for CLL or SLL.
• Previous exposure to BTKi and meet at least one of the criteria below:
• Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
• Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
• Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Resolution of toxicities due to prior BTKi therapy to acceptable level.
• Willingness of male and female patients to use medically acceptable methods of birth control.
• Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria

• Richter's transformation or prolymphocytic leukemia
• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• Received prior transplant
• Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
• Known central nervous system involvement by CLL/SLL