Non-Hodgkin Lymphoma Clinical Trials

• Subjects must meet all of the eligibility criteria to be enrolled on this study.

• Subjects ≥18 years of age at the time the ICF is signed.

• Have histologically confirmed FL, grades 1-3A

• Must have been previously treated with at least 1 prior systemic therapy followed by relapsed, refractory or progressive disease.

• a. Systemic therapy includes: i. Anti-CD20 monoclonal antibody in combination with chemotherapy ii. Anti-CD20 monoclonal antibody monotherapy iii. Anti-CD20 monoclonal antibody in combination with lenalidomide iv. Anti-CD20 monoclonal antibody plus investigational agent on protocol

• Requiring systemic therapy as assessed by investigator based on tumor size, location, and/or GELF criteria.

• Bi-dimensionally measurable disease, with at least one mass lesion ≥ 2 cm in longest diameter by CT, PET/CT, and/or MRI which was not previously irradiated.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Adequate renal function defined as calculated creatinine clearance per the Cockcroft and Gault formula

‣ In phase 1, creatinine clearance must be \>60 mL/minute

• Adequate bone marrow function:

∙ Absolute neutrophil count (ANC) ≥1,000/mm3 (≥1.0 × 109/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥0.75 × 109/L) with bone marrow infiltration, without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.

‣ Platelet ≥75,000/mm3 (≥75 × 109/L). Evaluated at least 7 days after platelet transfusion.

‣ Hemoglobin \> 8.0 g/dL. Evaluated at least 7 days after RBC transfusion.

• Adequate liver function:

∙ Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome (eg, a gene mutation in UGT1A1), who can have total bilirubin \<3.0 mg/dL.

‣ ALT and AST ≤3 × ULN.

⁃ International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0).

⁃ If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at Screening and must be willing to use 1 highly effective method and 1 additional effective birth control method upon enrollment, during the Treatment Period, and for 3 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test \>40 mIU/mL and estradiol \< 40 pg/mL (\<140 pmol/L).

⁃ If the subject is a male, the subject must be surgically sterile or willing to use a highly effective birth control upon enrollment, during the treatment period, and for 3 months following the last dose of study drug. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 3 months after the final study drug administration

⁃ Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 3 months after the final study drug administration. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.

⁃ All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.

⁃ Able and willing to provide written informed consent and to comply with the study protocol