To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Folli… (NCT04796922) | Clinical Trial Compass
WithdrawnPhase 3
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)
Stopped: This study was withdrawn due to a business decision.
0Started 2022-12-30
Plain-language summary
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) .
Who can participate
Age range18 Years
SexALL
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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 the…
What they're measuring
1
Progression Free Survival (PFS) in R/R FL and MZL participants