Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

AbbVie

Status and phase: Completed; Phase 1

Conditions: Lymphoma

Treatments: Drug: duvelisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02598570

M15-460

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

duvelisib

Experimental group

Description:

Duvelisib will be administered orally as a fixed dose in 28-day cycles.

Treatment:

Drug: duvelisib