Actively Recruiting
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-09
70
Participants Needed
9
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed mature T-cell lymphomas at the enrolling institution
- Includes relapsed or progressed stage b CTCL after at least two systemic therapies (max 15 CTCL patients in expansion)
- Systemic anaplastic large cell lymphoma relapsed after brentuximab vedotin therapy
- T-cell prolymphocytic leukemia (treatment naive permitted)
- At least one prior therapy for T-cell large granular lymphocytic leukemia, aggressive NK-cell leukemia, adult T-cell leukemia/lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, primary cutaneous gamma/delta T-cell lymphoma, primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with T follicular helper phenotype
- For T-PLL and TFH lymphoma expansion, histologies must be pathologically confirmed
- Age 18 years or older at enrollment
- ECOG performance status 2 or less
- Laboratory criteria including specific neutrophil, platelet, creatinine, bilirubin, AST, and ALT levels
- Measurable disease by specified clinical or laboratory criteria
- Ability to swallow pills
- Women of reproductive potential must have a negative pregnancy test within 14 days before therapy
- Agreement to use adequate birth control during the study and for 3 months after last dose
You will not qualify if you...
- Serious medical conditions, laboratory abnormalities, or psychiatric illness preventing informed consent
- Pregnant women; lactating women must agree not to breastfeed during treatment
- Prior allogeneic stem cell transplant within 6 months or active GVHD requiring immunosuppression
- Prior use of duvelisib or ruxolitinib discontinued due to toxicity
- Previous systemic anti-cancer therapy for T-cell lymphoma within 14 days before study drug
- Systemic corticosteroids exceeding prednisone 20mg/day at enrollment
- Ongoing use of immunosuppressants exceeding corticosteroids 20mg prednisone equivalent
- History of chronic liver disease, veno-occlusive disease, or current alcohol abuse
- Live vaccine within 6 weeks of first dose
- Prior surgery or gastrointestinal condition affecting drug absorption
- HIV infection with detectable viral load or low CD4 without antiretroviral therapy
- Chronic hepatitis B or C unless adequately treated and monitored
- Active CMV infection requiring therapy
- Unable or unwilling to receive prophylaxis against pneumocystis, herpes simplex, or herpes zoster
- Use of strong CYP3A inducers or inhibitors within 2 weeks before study
- Treatment for tuberculosis within 2 years prior
- Receiving therapy for another primary malignancy except certain skin cancers and after discussion
- Known central nervous system or meningeal involvement by T-cell lymphoma without symptoms
- Unstable or severe uncontrolled medical conditions increasing risk for study participation
AI-Screening
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Trial Site Locations
Total: 9 locations
1
University of Miami (Data Collection Only)
Miami, Florida, United States, 33125
Active, Not Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alison Moskowitz, MD
CONTACT
S
Steven Horwitz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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