Clinical trial · Interventional
A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
A Phase 1b, Open-Label, Dose-Escalation Study for the Safety, Tolerability, and Pharmacokinetics of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)
NCT03314922CI-TRIAL-00068735completedPhase 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)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell 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 |
|---|---|---|---|
| Parsaclisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Parsaclisib
- interventionNames
- Drug: Parsaclisib
Primary outcomes (1)
- measure
- Number of participants with treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to approximately 1 year
- description
- TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Secondary outcomes (4)
- measure
- Changes in pharmacodynamic (PD) markers of B-cell activation in plasma
- timeFrame
- Up to 24 weeks
- description
- Markers of B-cell activation (eg, B-cell activating factor, interleukin-10, B-cell attracting chemokine) and other plasma analytes will be analyzed for correlation with safety and clinical outcome.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * First generation Japanese; subject was born in Japan and has not lived outside of Japan for \> 10 years, and subject can trace maternal and paternal Japanese ancestry. * Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL. * Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available. * Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue. * Life expectancy \> 3 months. * Eastern Cooperative Oncology Group performance status of 0 to 2. * Adequate hematologic, hepatic, and renal function. Exclusion Criteria: * Evidence of transformed non-Hodgkin's lymphoma histologies. * Histologically confirmed, rare non-Hodgkin's B-cell subtypes. * History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. * Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor. * Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug. * Active graft-versus-host disease. * History of stroke or intracranial hemorrhage within 6 months of study drug administration. * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of the date of the first dose of study drug. * Known human immunodeficiency virus infection. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
References
Publications (0)
Data not yet available
No reference posted for this study.