Clinical trial · Interventional
To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was withdrawn due to a business decision.
Summary
Brief summary (as posted)
This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (MZL or FL) .
Conditions
Conditions (2)
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 ( FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Marginal Zone Lymphoma (MZL) | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| obinutuzumab | Drug | Obinutuzumab | ALIAS |
| parsaclisib | Drug | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group A
- description
- Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
- interventionNames
- Drug: parsaclisib
- Drug: rituximab
- Drug: obinutuzumab
- type
- PLACEBO_COMPARATOR
- label
- Treatment Group B
- description
- Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab
- interventionNames
- Drug: rituximab
- Drug: obinutuzumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) in R/R FL and MZL participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female participants aged 18 years or older (Japan, aged 20 years or older). * Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL * Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy) * Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb * Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014). * ECOG PS of 0 to 2 * Adequate organ functions including hematopoiesis, liver, and kidney * Willingness to avoid pregnancy or fathering children Exclusion Criteria: * Women who are pregnant or breastfeeding. * Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma). * Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease. * Prior treatment with PI3K inhibitors. * Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs. * Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease. * Known HIV infection. * HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA. * History of other malignancy within 2 years of study entry. * Any condition that would, in the investigator's judgment, interfere with full participation in the study.
References
Publications (0)
Data not yet available