Clinical trial · Interventional
Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma
NCT05867030CI-TRIAL-00070523withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Development strategy adjustment
Summary
Brief summary (as posted)
A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular 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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
| parsaclisib | Drug | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Parsaclisib+rituximab
- description
- parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1).
- interventionNames
- Drug: rituximab
- Drug: parsaclisib
- type
- EXPERIMENTAL
- label
- Parsaclisib+rituximab + lenalidomide
- description
- parsaclisib（2.5 mg QD，D1\~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles).
- interventionNames
- Drug: lenalidomide
- Drug: rituximab
- Drug: parsaclisib
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years old. 2. Histopathological diagnosis as FL Grade1, 2 or 3a 3. The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT). 4. Presence of radiographically measurable lymph nodes or extranodal lesions, defined as at least one lesion longest diameter (LD) measurements \> 1.5 cm and longest vertical diameter (LPD) measurements ≥1.0 cm. 5. Life expectancy ≥12 weeks. Exclusion criteria: 1. Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL). 2. A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease. 3. Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment. 4. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib). 5. pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.