Actively Recruiting
Phase I Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T-Cell and NK-Cell Lymphomas
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-09
70
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of the combination of ruxolitinib and duvelisib in people with relapsed or refractory NK-cell or T-cell lymphomas, including specific types like T-cell prolymphocytic leukemia and T-follicular helper lymphoma. The study is a Phase I trial designed to find out the effects of these drugs given at fixed and varying doses. It has three parts: dose escalation, dose expansion, and a cohort expansion for certain lymphoma subtypes. Participants will receive ruxolitinib 20mg twice daily combined with duvelisib at doses of 25mg, 50mg, or 75mg twice daily taken by mouth every 12 hours. The study uses a dose-escalation design to evaluate different doses of duvelisib alongside a fixed dose of ruxolitinib. Adjustments to doses can be made if deemed clinically favorable. The trial also includes an expansion phase for patients with specific lymphoma types to further evaluate treatment effects. During the study, participants will be monitored for safety and disease control at defined intervals, including assessments over one year to determine the optimal dose. Researchers will measure disease control rates at six months and monitor laboratory tests and clinical status. The study involves regular evaluations to track treatment effects and safety, with participation lasting according to the study schedule and treatment phases.
CONDITIONS
Brief Title
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at enrollment
- Pathologically confirmed mature T-cell lymphomas or NK-cell lymphomas
- Specific lymphoma types including CTCL stage 61b relapsed after two systemic therapies, systemic anaplastic large cell lymphoma relapsed after brentuximab vedotin, T-cell prolymphocytic leukemia (treatment naive permitted), and others as listed
- ECOG performance status of 2 or less
- Laboratory values meeting specified criteria for blood counts, creatinine, liver function
- Measurable disease by defined lymphoma criteria
- Ability to swallow pills
- Women of reproductive potential must have a negative pregnancy test and use effective contraception during and 3 months after treatment
You will not qualify if you...
- Serious medical condition or psychiatric illness preventing consent
- Pregnant or breastfeeding women
- Prior allogeneic stem cell transplant within 6 months or active GVHD requiring immunosuppression
- Prior use of duvelisib or ruxolitinib discontinued due to toxicity
- Recent systemic anti-cancer therapy within 14 days, with some exceptions
- Use of immunosuppressants exceeding specified doses
- History of chronic liver disease, veno-occlusive disease, or current alcohol abuse
- Live vaccine administration within 6 weeks prior to treatment
- Gastrointestinal conditions affecting drug absorption
- HIV infection with detectable viral load or low CD4 count without treatment
- Chronic hepatitis B or C without appropriate management
- Active CMV infection requiring therapy
- Inability to receive prophylaxis against certain infections
- Use of strong CYP3A inducers or inhibitors without appropriate washout
- Recent tuberculosis treatment within 2 years
- Therapy for another primary malignancy except some exceptions
- Known central nervous system involvement by lymphoma without symptoms
- Unstable or severe uncontrolled medical conditions increasing risk in study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable duration until disease progression or discontinuation
Participants receive oral doses of Ruxolitinib and Duvelisib twice daily, with dose adjustments based on clinical evaluation. Treatment duration varies as patients continue until disease progression or unacceptable toxicity.
Regular visits for dosing and monitoring as per protocol
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
S
Steven Horwitz, MD
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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