Clinical trial · Interventional
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
NCT02598570CI-TRIAL-00025797completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study seeks to evaluate the safety and pharmacokinetics of duvelisib in Japanese participants with relapsed or refractory lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| duvelisib | Drug | Duvelisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- duvelisib
- description
- Duvelisib will be administered orally as a fixed dose in 28-day cycles.
- interventionNames
- Drug: duvelisib
Primary outcomes (4)
- measure
- Number of participants reporting Treatment-emergent Adverse Events
- timeFrame
- Throughout the study for approximately 2 years
- description
- The number of participants reporting treatment-emergent adverse events.
- measure
- Maximum Observed Plasma Concentration (Cmax) of Duvelisib
- timeFrame
- Cycle 1 Day 1, 8, 15, and 22 and on Day 1 of Cycles 2 - 5
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.