Clinical trial NCT04796922: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Follicular Lymphoma ( FL)
Marginal Zone Lymphoma (MZL)
Keywords: parsaclisib
Relapsed/Refractory
obinutuzumab
rituximab
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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) .


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS) in R/R FL and MZL participants
timeFrame: 62 months
Secondary outcomes:
measure: Progression Free Survival (PFS) in R/R FL participants
timeFrame: 62 months
measure: Overall Response Rate (ORR)
timeFrame: 62 months
measure: Overall Survival (OS)
timeFrame: 10 years
measure: Progression Free Survival (PFS) in R/R MZL participants
timeFrame: 62 months
measure: Complete Response Rate (CRR)
timeFrame: 62 months
measure: Duration of Response (DOR)
timeFrame: 62 months
measure: Disease Control Rate (DCR)
timeFrame: 62 months
measure: Event Free Survival (EFS)
timeFrame: 62 months
measure: Time To Next antiLymphoma Therapy (TTNLT)
timeFrame: 62 months
measure: Progression-Free Survival on next antilymphoma therapy (PFS2)
timeFrame: 62 months
measure: Number of Treatment Emergent Adverse Events (TEAE's)
timeFrame: 62 months
Other outcomes:
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