A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Eligibility Criteria

• 1. Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
• 2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
• 3. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
• 1. Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed).
• 2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
• 3. c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN
• * Revised International Working Group Classification for systemic lymphoma19
• * Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
• * mSWAT (Modified Severity Weighted Assessment Tool) \>0
• * A woman of reproductive potential is a sexually-mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
• * The effects of duvelisib on conception, pregnancy, and lactation are unknown. Since duvelisib has not been evaluated in pregnant or nursing women, the treatment of pregnant women or women of childbearing potential who are not using a highly effective contraception is contraindicated.
• 1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• 2. Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
• 3. Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression.
• * Subjects with a negative HBsAg and a positive HBcAb require an undetectable/negative hepatitis B DNA test (e.g., polymerase chain reaction \[PCR\] test) to be enrolled, and must receive hepatitis B prophylaxis until at least 6 months after completion of study drug(s).
• * Such agents must be discontinued at least 2 weeks prior to study intervention
• * Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions n) Receipt of treatment for tuberculosis within 2 years prior to enrollment
• * Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
• * Early-stage cutaneous basal cell and squamous cell carcinomas are permissible
• * Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.