ClinicalTrials.gg
Active, not recruitingNCT05010005Updated Nov 5, 2026

A Study of Ruxolitinib and Duvelisib in People With Lymphoma

A Phase 1 interventional study of Ruxolitinib and Duvelisib in T-cell Lymphomas, NK-Cell Lymphomas and T-cell Prolymphocytic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment

Updated Nov 5, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

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

Keywords

  • mature T-cell lymphomas
  • Ruxolitinib
  • Duvelisib
  • Relapsed or Refractory
  • 21-176
  • T-cell Large Granular Lymphocyte Leukemia
  • T-cell Prolymphocytic Leukemia
03

In context

Lymphoma, T-Cell

310 studies on the registry are indexed under Lymphoma, T-Cell; 78 are open to participants now.

This study's enrollment of 80 is above the median of 37 across 270 interventional studies indexed under Lymphoma, T-Cell.

Browse Lymphoma, T-Cell 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

a) -confirmed mature T-cell lymphomas at the enrolling institution.

Permitted histologies include (for dose escalation and expansion):

i) Stage ≥Ib CTCL, which has 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 grading system, ≤2

e) Laboratory criteria.

Laboratory criteria

i) For dose escalation phase:

  1. ≥1.0 K/mcL (Note: growth factor is allowed)
  2. count ≥80 K/μl or ≥50 K/μl if due to lymphoma
  3. Creatinine ≤1.5 × OR Measured calculated ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN

i. Creatinine clearance should be calculated per institutional standard

d. Direct ≤1.5x upper limit of normal (ULN) or ≤3x ULN if documented hepatic involvement with lymphoma, or ≤5x ULN if history of Gilbert's syndrome; and ALT ≤ 3x ULN; or ≤ 5x ULN if due to lymphoma involvement

ii) For dose expansion phase and T-PLL/TFH lymphoma expansion:

  1. Absolute neutrophil count ≥1.0 K/mcL or ≥0.5 K/mcL if due to lymphoma or ≥0.0 K/mcL if due to T-PLL or large granular lymphocytic leukemia (LGL) (Note: growth factor is allowed).
  2. Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
  3. c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN

i. Creatinine clearance should be calculated per institutional standard d. Direct bilirubin ≤1.5x upper limit of normal (ULN) or ≤3x ULN if documented hepatic involvement with lymphoma, or ≤5x ULN if history of Gilbert's syndrome; AST and ALT ≤ 3x ULN; or ≤ 5x ULN if due to lymphoma involvement

f) , defined by at least one of the following:

  • 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

    g) Ability to swallow pills

    h) Women of * must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test within 14 days of initiating therapy. All women of reproductive potential and all sexually active male patients must agree to use adequate methods of (e.g. latex condoms) throughout the study and for 3 months after the last dose of study drug.

    • A woman of reproductive potential is a sexually-mature woman 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).
  • 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 who are not using a highly effective contraception is .

Exclusion criteria

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the form.
  2. Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
  3. Prior stem cell transplant within 6 months of starting treatment or patients with active requiring .

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 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 must be tapered to 20mg/day or less prednisone (or equivalent) upon start of 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 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 infection if they meet either of the below criteria:

i. detectable viral load ii. undetectable viral load with \<200 or not taking anti-retroviral medications.

k) Patients with chronic 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

  • 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 (other than T-cell lymphoma).

  • 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
  • or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.

    p) Known central nervous system or meningeal involvement by TCL (in the absence of symptoms, investigation into central nervous system involvement is not required).

    q) Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition) or any important medical illness that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.

Terms in these criteria, in plain language(29)

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.

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.

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.

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.

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.

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.

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.

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.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

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.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Ruxolitinib and Duvelisib

    Ruxolitinib 20mg BID plus Duvelisib 25mg, 50mg, or 75mg BID. Patients will be instructed to take duvelisib and ruxolitinib by mouth every 12 hours, the same time each day, +/- 2 hours. Duvelisib and ruxolitinib will be provided via the institutional investigational pharmacy. The researchers will utilize a dose-escalation standard 3+3 design in which we evaluate 3 doses of duvelisib (25mg BID, 50mg BID, and 75mg BID) in combination with ruxolitinib 20mg BID. A minus-1 dose level of duvelisib (15mg BID) can be used if de-escalation is needed. The cohort expansion phase will have two treatment groups JAK/STAT activation or mutation present or JAK/STAT activation or mutation absent or unknown. Upon discussion with PI, the treating physician may increase dose up to 20 mg of ruxotlinib and/or 25 mg of duvelisib when deemed clinically favorable. T-prolymphocytic leukemia (T-PLL) and T-follicular helper (TFH) lymphoma expansion: Further expansion for patients with T-PLL and TFH lymphomas.

    Drug: Ruxolitinib · Drug: Duvelisib

Interventions

06

What researchers measure

Primary outcomes

  1. Assessment for MTD/optimal dose

    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.

    Time frame: 1 year

Secondary outcomes

  1. Estimate the disease control rate

    combined complete response, partial response, and stable disease for 6 months with improvement in cytopenia

    Time frame: 6 months

  2. Estimate the disease control rate (R+D in patients with T-PLL and TFH lymphomas)

    combined complete response and partial response , and stable disease for 6 months with improvement in cytopenia

    Time frame: 6 months

07

Study locations

9 sites
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Nov 5, 2026
Enrollment
70 (estimated)→80 (actual)
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Recruiting→Active, not recruiting
    Enrollment 70 (estimated)→80 (actual)
    + 3 other changes: verification date, contact details and site details

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
NCT05010005
Responsible party
Sponsor
First posted
Aug 18, 2021
Start date
Aug 12, 2021
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Alison Moskowitz, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ruxolitinib · Duvelisib

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