ClinicalTrials.gg
RecruitingNCT02974647Updated Oct 23, 2026

Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

A Phase 2 interventional study of Ruxolitinib in Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Updated Oct 23, 20261 site added1 site removedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
83
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. Ruxolitinib works by blocking a protein called JAK. JAK works along with another protein called STAT and is important for survival of many T or NK-cell lymphomas. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.

02

Conditions studied

  • Lymphoma

Keywords

  • Ruxolitinib
  • T or NK Cell
  • Relapsed
  • Refractory
03

In context

Lymphoma

3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.

This study's planned enrollment of 83 is above the median of 43 across 2,319 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed T or NK cell lymphoma at the enrolling institution. For CTCL, patients with stage IB disease or greater are eligible.
  • Relapse or disease after at least 1 systemic therapy except for T-PLL, LGL, or T-cell Lymphoproliferative diseases with JAK2 fusion.
  • Untreated patients may be allowed after discussion with P.I.
  • Age ≥ 18
  • ≤ 2
  • defined by:

    • Lugano Classification for systemic lymphoma or
    • Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood or bone marrow or
    • mSWAT > 0 or Sezary count ≥ 1000 cells/μL for CTCL
  • Previous systemic anti-cancer therapy for T-cell lymphoma must have been discontinued at least 2 weeks prior to treatment.

    • aimed at controlling lymphoma-related symptoms are allowed as long as they are tapered down to 20mg or less by the time of ruxolitiib initiation
    • Topical steroids for CTCL are permitted
    • See section 6.2 Subject Exclusion Criteria for guideline regarding and maintenance therapy for prior
  • Patients must meet the following lab criteria:

    • ≥ 1.0/mm\^3 or ANC >/= 0.5/mm\^3 (if patient has baseline neutropenia due to lymphoma), ≥ 100 x 10\^9/L or ≥ 50 x 10\^9/L (if related to lymphoma), ≥ 8g/dL
    • Patients with LGL or T-PLL are not required to meet a minimum ANC or hemoglobin value for eligibility
    • Total ≤ 1.5 x (ULN) or; ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's ; and ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma involvement
    • ≥ 30 mL/min; creatinine clearance of 15-29 mL/min will be allowed as long as baseline platelets are ≥ 150 x 10\^9/L
  • For patients with positive core antibody or surface antigen, hepatitis B PCR must be negative and prophylaxis with entecavir or equivalent is required.
  • Patients with are allowed provided that they are on anti-retroviral treatment with no active infections.

Exclusion criteria

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the form.
  • Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • performance status >2
  • Prior therapy with ruxolitinib
  • Receiving systemic therapy for another primary (other than T-cell lymphoma)

    • Patients with more than one type of lymphoma may be enrolled after discussion with the MSK Principal Investigator
    • or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal Investigator
  • Women of † must have a negative Serum ß human chorionic gonadotropin (ß-HCG) pregnancy test.

    • A female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (estimated)

Study arms

  • Experimental
    rel/ref PTCLtumors are known to contain mutations associ

    Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

    Drug: Ruxolitinib

  • Experimental
    with rel/ref PTCL with functional evidence of JAK/STAT

    Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

    Drug: Ruxolitinib

  • Experimental
    with rel/ref PTCL who do not meet criteria for cohort 1 or 2.

    Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

    Drug: Ruxolitinib

  • Experimental
    Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.

    Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.

    Drug: Ruxolitinib

Interventions

06

What researchers measure

Primary outcomes

  1. disease control rate

    defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold.

    Time frame: 2 years

07

Study locations

6 of 10 sites recruiting
  • University of Miami
    Miami, Florida, United States
    Active, not recruiting

    Not enrolling at this site.

  • Northwestern Medicine (Data collection and specimen analysis)
    Chicago, Illinois 60611, United States
    Active, not recruiting

    Not enrolling at this site.

  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
    Active, not recruiting

    Not enrolling at this site.

  • Memorial Sloan Kettering Basking Ridge
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Alison Moskowitz, MD · Contact212-639-4839
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Alison Moskowitz, MD · Contact212-639-4839
  • Memorial Sloan Kettering Commack
    Commack, New York 11725, United States
    Recruiting
    • Alison Moskowitz, MD · Contact212-639-4839
  • Memorial Sloan Kettering Westchester
    Harrison, New York 10604, United States
    Recruiting
    • Alison Moskowitz, MD · Contact212-639-4839
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Alison Moskowitz, MD · Contact212-639-4839
    • Steven Horwitz, MD · Contact212-639-3045
    • Allison Moskowitz, MD · Principal investigator
  • Weill Cornell Medical College
    New York, New York, United States
    Active, not recruiting

    Not enrolling at this site.

  • Memorial Sloan Kettering Nassau (All Protocol Activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Alison Moskowitz, MD · Contact212-639-4839
08

References and documents

Publications

  • Moskowitz AJ, Ghione P, Jacobsen E, Ruan J, Schatz JH, Noor S, Myskowski P, Vardhana S, Ganesan N, Hancock H, Davey T, Perez L, Ryu S, Santarosa A, Dowd J, Obadi O, Pomerantz L, Yi N, Sohail S, Galasso N, Neuman R, Liotta B, Blouin W, Baik J, Geyer MB, Noy A, Straus D, Kumar P, Dogan A, Hollmann T, Drill E, Rademaker J, Schoder H, Inghirami G, Weinstock DM, Horwitz SM. A phase 2 biomarker-driven study of ruxolitinib demonstrates effectiveness of JAK/STAT targeting in T-cell lymphomas. Blood. 2021 Dec 30;138(26):2828-2837. doi: 10.1182/blood.2021013379. PubMed 34653242 ↗
09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Memorial Sloan Kettering Westchester · Harrison, United States
Show 1 removed
  • Memorial Sloan Kettering Westchester · East White Plains, United States
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    1 site added, 1 site removed
    Show site
    • Memorial Sloan Kettering Westchester · Harrison, United States
    Show 1 removed
    • Memorial Sloan Kettering Westchester · East White Plains, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02974647
Responsible party
Sponsor
First posted
Nov 28, 2016
Start date
Nov 2016
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Alison Moskowitz, MD
Contact
212-639-4839
Steven Horwitz, MD
Contact
212-639-3045
Alison Moskowitz, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

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