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Study of Ruxolitinib and Duvelisib for Lymphoma

This study is testing the safety of two drugs, ruxolitinib and duvelisib, in people with certain types of lymphoma, including T-cell lymphomas and NK-cell lymphomas. You might be able to join if you are 18 or older and have a confirmed mature T-cell lymphoma that has come back or gotten worse after at least two other treatments. Ruxolitinib will be given at a consistent dose, while duvelisib will be given at different doses (25mg, 50mg, or 75mg) to see which is best. The main goal is to find the safest and most effective dose of duvelisib when given with ruxolitinib, which will be assessed over one year. The current status of this study is unclear, but it plans to enroll about 70 participants.

Study design
This is an interventional study with an unspecified phase. It involves three parts: dose escalation, dose expansion, and a specific cohort expansion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, assessing the optimal dose, is measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05010005

A Study of Ruxolitinib and Duvelisib in People With Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~70 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:RuxolitinibDuvelisib

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment for MTD/optimal dose
Measured over 1 year

Conditions

T-cell Lymphomas
NK-Cell Lymphomas
T-cell Prolymphocytic Leukemia
T-cell Large Granular Lymphocyte Leukemia

Explore related trials

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NCT05010005

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dana Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alison Moskowitz, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Alison Moskowitz, MD
[email protected]
646-608-3726
Email the study team

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Eligibility criteria

Inclusion

Revised International Working Group Classification for systemic lymphoma19
Atypical T lymphocytes quantifiable by flow cytometry or morphology in the peripheral blood or bone marrow
mSWAT (Modified Severity Weighted Assessment Tool) \>0
A woman of reproductive potential is a sexually-mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
The effects of duvelisib on conception, pregnancy, and lactation are unknown. Since duvelisib has not been evaluated in pregnant or nursing women, the treatment of pregnant women or women of childbearing potential who are not using a highly effective contraception is contraindicated.

Exclusion

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).
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
Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator.
Early-stage cutaneous basal cell and squamous cell carcinomas are permissible
Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.

What this trial measures

  • Assessment for MTD/optimal dose1 year

    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.