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

JRCT ID: jRCT2031210296

Registered date:05/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Follicular Lymphoma (FL) , Marginal Zone Lymphoma (MZL)
• Date of first enrollment: 30/12/2022
• Target sample size: 0
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Progression Free Survival (PFS) in R/R FL and MZL participants

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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
- Willingness to avoid pregnancy or fathering children

Exclude 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.
- 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.

Related Information

• Primary Sponsor: Ueda Eiji
• Secondary ID(s): NCT04796922