Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

An Open-Label, Single-Arm, Multicenter Phase 1 Study Evaluating the Safety and Pharmacokinetics of Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.

Inclusion Criteria:

• Diagnosis of lymphoma (excluding lymphoblastic lymphoma)
• Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease for which there is no established therapy
• Eastern Cooperative Oncology Group (ECOG) performance status lower than or equal to 2
• Life expectancy of at least 3 months

Exclusion Criteria:

• Any prior treatment with a PI3K inhibitor or Bruton's tyrosine kinase (BTK) inhibitor
• Ongoing treatment with chronic immune-suppressants
• Overt CNS lymphoma
• Inadequate hepatic, bone marrow, or renal function
• History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
• Venous thromboembolic event requiring anticoagulation
• Presence of active systemic infection within 72 hours of treatment
• Human immunodeficiency virus (HIV) infection
• Pregnant or lactating women