Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

AbbVie7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

Interventions

duvelisibDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (3)

Site Reference ID/Investigator# 141826

Aichi, Japan

Site Reference ID/Investigator# 141595

Fukuoka, Japan

Site Reference ID/Investigator# 141594

Tokyo, Japan

Outcomes

Primary Outcomes

Number of participants reporting Treatment-emergent Adverse Events

The number of participants reporting treatment-emergent adverse events.

Time frame: Throughout the study for approximately 2 years

Maximum Observed Plasma Concentration (Cmax) of Duvelisib

Time frame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5

Time to Maximum Observed Concentration (Tmax) of Duvelisib

Time frame: 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

Time frame: Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Throughout the study for approximately 2 years

Data from ClinicalTrials.gov

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