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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210296

Registered date:05/09/2021

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedFollicular Lymphoma (FL) , Marginal Zone Lymphoma (MZL)
Date of first enrollment29/10/2021
Target sample size416
Countries of recruitmentU.S.A,Japan
Study typeInterventional
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 OutcomeProgression Free Survival (PFS) in R/R FL and MZL participants
Secondary Outcome1.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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Development Operations
Address Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006
Telephone +81-3-6625-7500
E-mail japan_clinicaltrials@incyte.com
Affiliation Incyte Biosciences Japan G.K.
Scientific contact
Name Eiji Ueda
Address Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006
Telephone +81-3-6625-7500
E-mail japan_clinicaltrials@incyte.com
Affiliation Incyte Biosciences Japan G.K.