Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Official Title
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A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: parsaclisib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Japanese participant who must be ≥ 18 years of age Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a Ineligible for HSCT Must have been treated with at least 2 prior systemic therapies for FL Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LD and ≥ 1.0 cm in the LPD, respectively) as assessed by CT or MRI Participants must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy collected after the completion of last therapy. An earlier archived lymph node or tissue biopsy is acceptable if hospitalization is required for biopsy (eg. no superficial lymph node) and SUVmax by FDG-PET is < 14 ECOG performance status 0 to 2 Life expectancy ≥ 12 weeks Adequate hematologic, hepatic, and renal functions ANC ≥ 1.0 × 109/L Hemoglobin ≥ 8.0 g/dL. Platelet count ≥ 50 × 109/L. Total bilirubin ≤ 1.5 × ULN. Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible. ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. Calculated creatinine clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula. Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration. Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study. Male participants should avoid fathering children from screening through at least 93 days after the last dose of study treatment. Exclusion Criteria: Known histological transformation from indolent NHL to DLBCL History of central nervous system lymphoma (either primary or metastatic) Prior treatment with the following: Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc). Bruton's tyrosine kinase inhibitor (eg, ibrutinib). Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration Active graft-versus-host disease Use of immunosuppressive therapy within 28 days of the date of study treatment administration Concurrent anticancer therapy Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval. Hepatitis B (HBV) or HCV infection Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: parsaclisib<br>parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits | Drug: parsaclisib<br>* parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits<br>* Other names: INCB050465;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014), as determined by an IRC | Up to approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate (CRR) | Defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas (Cheson et al 2014), as determined by an IRC. | Up to approximately 2 years | 
| Duration of response (DOR) | Defined as the time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC. | Up to approximately 2 years | 
| Progression-free survival (PFS) | Defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. | Up to approximately 2 years | 
| Overall survival | Defined as the time from the date of the first dose of study treatment until death from any cause | Up to approximately 2 years | 
| Best percentage change in target lesion size | Best percentage change in target lesion size from baseline, where target lesion size is measured by the sum of the product of the diameters of all target lesion sizes. | Up to approximately 2 years | 
| Number of participants with treatment-emergent adverse events (TEAEs) | TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular Lymphoma, Parsaclisib, PI3Kδ Inhibitor