Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

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

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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: duvelisib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: duvelisib<br>Duvelisib will be administered orally as a fixed dose in 28-day cycles. | Drug: duvelisib<br>* Duvelisib will be administered orally as a fixed dose in 28-day cycles.<br>* Other names: ABBV-954;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting Treatment-emergent Adverse Events | The number of participants reporting treatment-emergent adverse events. | Throughout the study for approximately 2 years | 
| Maximum Observed Plasma Concentration (Cmax) of Duvelisib |  | Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5 | 
| Time to Maximum Observed Concentration (Tmax) of Duvelisib |  | Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5 | 
| Area Under the Plasma Concentration-time Curve (AUC) of Duvelisib |  | Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Overall Response Rate is defined as the proportion of participants with a confirmed response of complete (CR) or partial response (PR) based on the revised International Working Group (IWG) criteria. | Throughout the study for approximately 2 years | 
| Overall Survival | Overall survival is defined as the duration in weeks from the date of the first dose of study treatment until the date of death. | Throughout the study for approximately 2 years | 
| Progression Free Survival | Progression free survival is defined as the time from the date of the first dose of study treatment to the first documentation of progressive disease (PD) or death due to any cause. | Throughout the study for approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma