This study will test the safety of ruxolitinib, given at one dose that does not change, and duvelisib, given at different doses, to find out what effects, if any, the study treatment has on people with relapsed or refractory NK-cell or T-cell lymphoma.
This study has three parts: dose escalation (Part 1), dose expansion (Part 2), and TFH/T-PLL cohort expansion (Part 3).
Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
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).
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
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).
Sequential
Ruxolitinib
DrugRuxolitinib 20mg BID
Duvelisib
DrugDuvelisib 25mg, 50mg, or 75mg BID
Assessment for MTD/optimal dose
3 subjects will be enrolled and followed for eight weeks of safety assessments. If no DLT is observed after all three subjects have been observed for eight weeks, a second cohort of 3 subjects will be enrolled at the next highest dose level. Cohorts will continue to be enrolled and observed until one subject experiences a DLT or the maximum dose level is reached with 0 or 1/6 DLTs.
Estimate the disease control rate
combined complete response, partial response, and stable disease for 6 months with improvement in cytopenia
Estimate the disease control rate (R+D in patients with T-PLL and TFH lymphomas)
combined complete response and partial response , and stable disease for 6 months with improvement in cytopenia
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