T-cell LymphomasPhase 1NCT05010005
A Study of Ruxolitinib and Duvelisib in People With Lymphoma
A Phase 1 study testing Ruxolitinib and Duvelisib in people with T-cell Lymphomas and NK-Cell Lymphomas, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Lymphomas, NK-Cell Lymphomas, T-cell Prolymphocytic Leukemia
- What is being tested?
- Ruxolitinib and Duvelisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesUnited States
- Study dates
- 12 Aug 2021to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically-confirmed mature T-cell lymphomas at the enrolling institution.
- Permitted histologies include (for dose escalation and expansion):
- Stage ≥Ib CTCL, which has relapsed 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.
- Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin.
- 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):
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- 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
- xviii) Nodal peripheral T-cell lymphoma wih T follicular helper phenotype
- 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)
- Age ≥18 years at time of enrollment
- Performance status, as assessed in the ECOG grading system, ≤2
- Laboratory criteria.
- Laboratory criteria
- For dose escalation phase:
- Absolute neutrophil count ≥1.0 K/mcL (Note: growth factor is allowed)
- Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
- Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- Creatinine clearance should be calculated per institutional standard
- 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
- For dose expansion phase and T-PLL/TFH lymphoma expansion:
- 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).
- Platelet count ≥80 K/μl or ≥50 K/μl if due to lymphoma
- c. Creatinine ≤1.5 × ULN OR Measured calculated creatinine clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN
- 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
- Measurable disease, 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
- Ability to swallow pills
- Women of reproductive potential* 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 birth control (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 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.
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
- Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression.
- Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment...
- Prior use of duvelisib or ruxolitinib if either agent was discontinued due to toxicity.
- Previous systemic anti-cancer therapy for TCL within 14 days of initiating study drug
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- Patients who have received localized RT as part of their immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator.
- Patients receiving treatment with single agent ruxolitinib or duvelisib may be allowed to enroll onto the study without a washout period
- Systemic corticosteroids must be tapered to 20mg/day or less prednisone (or equivalent) upon start of investigational treatment.
- Topical steroids for CTCL is permitted on study.
- Ongoing use of immunosuppressant medications, including corticosteroids greater than 20mg of prednisone or equivalent at the time of enrollment
- History of chronic liver disease, veno-occlusive disease, or current alcohol abuse
- Administration of a live vaccine within 6 weeks of first dose of study drug.
- Prior surgery or gastrointestinal condition that may adversely affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
- Patients with HIV infection if they meet either of the below criteria:
- detectable viral load ii. undetectable viral load with CD4 count <200 or not taking anti-retroviral medications.
- Patients with chronic hepatitis B 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).
- 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.
- Unable or unwilling to receive prophylaxis against pneumocystis, herpes simplex virus, or herpes zoster
- Use of medications or consumption of foods that are strong inducers or inhibitors of CYP3A
- 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
- Receiving therapy for another primary malignancy (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
- Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy is potentially permissible after discussion with the MSK Principal Investigator.
- Known central nervous system or meningeal involvement by TCL (in the absence of symptoms, investigation into central nervous system involvement is not required).
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
University of Miami (Data Collection Only)
Miami, Florida, 33125
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas
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
- T-cell Lymphomas, NK-Cell Lymphomas, T-cell Prolymphocytic Leukemia, T-cell Large Granular Lymphocyte Leukemia
- Being tested
- Ruxolitinib, Duvelisib
- Keywords
- mature T-cell lymphomas, Ruxolitinib, Duvelisib, Relapsed or Refractory, 21-176, T-cell Large Granular Lymphocyte Leukemia, T-cell Prolymphocytic Leukemia
- Medical subject headings
- Lymphoma, T-Cell, Leukemia, Prolymphocytic, T-Cell, Leukemia, Large Granular Lymphocytic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Ruxolitinib 20mg BID
DuvelisibDrug
Duvelisib 25mg, 50mg, or 75mg BID
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib and Duvelisib | Experimental | 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. Receives: Drug: Ruxolitinib; Drug: Duvelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
Estimate the disease control rate
combined complete response, partial response, and stable disease for 6 months with improvement in cytopenia
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start12 Aug 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell LymphomasStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This phase I study includes a dose escalation phase and a dose expansion phase.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison Moskowitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010005
- Sponsor's protocol ID
- 21-176
- Status last verified
- Nov 2026
- First submitted
- 12 Aug 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT05010005
- Acronym / sponsor ID
- 21-176
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This phase I study includes a dose escalation phase and a dose expansion phase.
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib and Duvelisib | Experimental | Drug: Ruxolitinib, Drug: DuvelisibRuxolitinib 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (45 listed)
- Pathologically-confirmed mature T-cell lymphomas at the enrolling institution.
- Stage ≥Ib CTCL, which has relapsed 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.
- Systemic anaplastic large cell lymphoma that has relapsed after therapy containing brentuximab vedotin.
- 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):
Key exclusion criteria (29 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant women. (Lactating women must agree not to breast feed while taking study medications).
- Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active GVHD requiring immunosuppression.
- Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment...
- Prior use of duvelisib or ruxolitinib if either agent was discontinued due to toxicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibRuxolitinib 20mg BID | Drug | Ruxolitinib and Duvelisib |
| DuvelisibDuvelisib 25mg, 50mg, or 75mg BID | Drug | Ruxolitinib and Duvelisib |
Primary outcome
Assessment for MTD/optimal dose
Time frame: 1 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.
2 secondary outcomes
Estimate the disease control rate
Time frame: 6 months
Estimate the disease control rate (R+D in patients with T-PLL and TFH lymphomas)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Moskowitz, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib and Duvelisib in people with T-cell Lymphomas and NK-Cell Lymphomas, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 45 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment for MTD/optimal dose (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.