Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas
Memorial Sloan Kettering Cancer Center
Summary
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: a) Pathologically-confirmed mature T-cell lymphomas at the enrolling institution. Permitted histologies include (for dose escalation and expansion): i) Stage ≥Ib CTCL, which has relapsed or progressed after at least two systemic therapies. In order to ensure balanced enrollment for patients with systemic T-cell lymphoma and CTCL, a maximum of 15 CTCL patients will be enrolled in expansion cohort. ii) Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin. iii) T-cell prolymphocytic leukemia (treatment naïve permitted) Fo…
Interventions
- DrugRuxolitinib
Ruxolitinib 20mg BID
- DrugDuvelisib
Duvelisib 25mg, 50mg, or 75mg BID
Locations (9)
- University of Miami (Data Collection Only)Miami, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities)Commack, New York