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

Incyte

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Treatments

Drug: parsaclisib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04434937

INCB 50465-213

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
1. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
2. 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