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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 (CITADEL-302)

Ueda Eiji

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

jpmedinfo@incyte.com

Medical Information Center

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

+81-120-094-139

jpmedinfo@incyte.com

Complete

Dec. 30, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

- 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
- Willingness to avoid pregnancy or fathering children

- 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.
- Adequate organ functions including hematopoiesis, liver, and kidney
- 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.

Both

Follicular Lymphoma (FL) , Marginal Zone Lymphoma (MZL)

Parallel Assignment
Group A : parsaclisib + rituximab + obinutuzumab
parsaclisib (INCB050465) will be administered once daily for 8 weeks.
rituximab will be administered intravenously on select days as per protocol.
obinutuzumab will be administered intravenously on select days as per protocol.

Group B : rituximab + obinutuzumab
rituximab will be administered intravenously on select days as per protocol.
obinutuzumab will be administered intravenously on select days as per protocol.

Progression Free Survival (PFS) in R/R FL and MZL participants

1. Progression Free Survival (PFS) in R/R FL participants
2. Overall Response Rate (ORR)
3. Overall Survival (OS)
4. Progression Free Survival (PFS) in R/R MZL participants
5. Complete Response Rate (CRR)
6. Duration of Response (DOR)
7. Disease Control Rate (DCR)
8. Event Free Survival (EFS)
9. Time To Next anti Lymphoma Therapy (TTNLT)
10. Progression-Free Survival on next anti lymphoma therapy (PFS2)
11. Number of Treatment Emergent Adverse Events (TEAE's)

+81-43-264-5431

Yes

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

none