Clinical trial · Interventional
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
NCT03144674CI-TRIAL-00092046completedPhase 2Results postedClinicalTrials.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 and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
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 (2)
- type
- EXPERIMENTAL
- label
- Cohort 1- Closed to Further enrollment
- description
- Participants who have received prior ibrutinib.
- interventionNames
- Drug: Parsaclisib
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Participants who have not received a prior BTK inhibitor.
- interventionNames
- Drug: Parsaclisib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) Based on Lugano Classification Criteria
- timeFrame
- Up to approximately 161 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and women, aged 18 or older (except in South Korea, aged 19 or older). * Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and splenic subtypes. * Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter. * Participants with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed. * Participants must be willing to undergo an incisional or excisional lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue. * Eastern Cooperative Oncology Group performance status 0 to 2. Exclusion Criteria: * Evidence of diffuse large B-cell transformation. * History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. * Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-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 treatment. * Active graft versus host disease. * Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
References
Publications (0)
Data not yet available
No reference posted for this study.