Lymphoma
Conditions
Keywords
Relapsed Lymphoma, Phosphoinositide 3-kinase (PI3K) Inhibitor, Duvelisib, Japanese, Refractory Lymphoma
Brief summary
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
Interventions
DRUGduvelisib
Duvelisib will be administered orally as a fixed dose in 28-day cycles.
Sponsors
Infinity Pharmaceuticals, Inc.
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reporting Treatment-emergent Adverse Events | Throughout the study for approximately 2 years | The number of participants reporting treatment-emergent adverse events. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Throughout the study for approximately 2 years | Overall survival is defined as the duration in weeks from the date of the first dose of study treatment until the date of death. |
| Progression Free Survival | Throughout the study for approximately 2 years | 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. |
| Overall Response Rate | Throughout the study for approximately 2 years | 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. |
Countries
Japan
Outcome results
None listed