- 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
- 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.
- 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,
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
- 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