A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Recruiting now · Phase 1

Conditions studied: T-cell Lymphomas, NK-Cell Lymphomas, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocyte Leukemia

In brief

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).

Key facts

Study ID

NCT05010005

Run by

Memorial Sloan Kettering Cancer Center

People needed

70

Starts

2021-08-12

Expected to finish

2027-08-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• For the following histologies, patients are required to have received at least 1 prior therapy (dose escalation and expansion):
• iv) T-cell large granular lymphocytic leukemia
• v) Aggressive NK-cell leukemia
• vi) Adult T-cell leukemia/lymphoma
• vii) Extranodal NK/T- cell lymphoma, nasal type
• viii) Enteropathy-associated T-cell lymphoma
• ix) Monomorphic epitheliotropic intestinal t-cell lymphoma
• x) Hepatosplenic T cell lymphoma
• xi) Subcutaneous panniculitis-like T-cell lymphoma
• xii) Primary cutaneous anaplastic large cell lymphoma
• xiii) Primary cutaneous gamma/delta T-cell lymphoma
• xiv) Primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma
• xv) Peripheral T-cell lymphoma, not otherwise specified
• xvi) Angioimmunoblastic T cell lymphoma
• xvii) Follicular T-cell lymphoma
• xviii) Nodal peripheral T-cell lymphoma wih T follicular helper phenotype
• b) Nodal periphal T-cell lymphoma wih T follicular helper phenotype Specific for T-PLL and TFH lymphoma expansion: histologies must be pathologically confirmed at the enrolling institutions i) T-cell prolymphocytic leukemia (treatment naïve permitted) ii) T-follicular helper lymphomas (must have received at least 1 prior treatment)
• c) Age ≥18 years at time of enrollment
• d) Performance status, as assessed in the ECOG grading system, ≤2
• e) Laboratory criteria.

You may not qualify if…

• 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.
• a. Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment...
• d) Prior use of duvelisib or ruxolitinib if either agent was discontinued due to toxicity.
• e) Previous systemic anti-cancer therapy for TCL within 14 days of initiating study drug
• a. Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator.
• i. Patients receiving treatment with single agent ruxolitinib or duvelisib may be allowed to enroll onto the study without a washout period
• b. Systemic corticosteroids must be tapered to 20mg/day or less prednisone (or equivalent) upon start of investigational treatment.
• c. Topical steroids for CTCL is permitted on study.
• f) Ongoing use of immunosuppressant medications, including corticosteroids greater than 20mg of prednisone or equivalent at the time of enrollment
• g) History of chronic liver disease, veno-occlusive disease, or current alcohol abuse
• h) Administration of a live vaccine within 6 weeks of first dose of study drug.
• i) Prior surgery or gastrointestinal condition that may adversely affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
• j) Patients with HIV infection if they meet either of the below criteria:
• i. detectable viral load ii. undetectable viral load with CD4 count <200 or not taking anti-retroviral medications.
• k) Patients with chronic hepatitis B or C as defined by positive hepatitis B or C serology:
• 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).
• l) Subjects with active CMV (defined as positive CMV PCR with clinical manifestations consistent with active CMV infection) and requiring therapy. Carriers will be monitored per institutional guidelines.
• m) Unable or unwilling to receive prophylaxis against pneumocystis, herpes simplex virus, or herpes zoster
• g) Use of medications or consumption of foods that are strong inducers or inhibitors of CYP3A
• 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
• o) Receiving therapy for another primary malignancy (other than T-cell lymphoma).
• Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.

Where it is running

• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Miami (Data Collection Only) — Miami, Florida, United States

Full record on ClinicalTrials.gov

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