Who is eligible for clinical trial NCT05010005?

Participants must meet the protocol's inclusion criteria for T-cell Lymphomas. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05010005 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-06

A Study of Ruxolitinib and Duvelisib in People With Lymphoma (NCT05010005)

Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (10 items).

Location: University of Miami (Data Collection Only) — Miami, Florida

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

a) Pathologically-confirmed mature T-cell lymphomas at the enrolling institution. Permitted histologies include (for dose escalation and expansion): i) 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. 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 ECOG grading system, ≤2 e) Laboratory criteria. Laboratory criteria i) 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 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 ii) 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 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) 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 g) Ability to swallow pills h) 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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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. 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 washout period 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 corticosteroids must be tapered to 20mg/day or less prednisone (or equivalent) upon start of investigational 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 live vaccine 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 HIV infection if they meet either of the below criteria: i. detectable viral load ii. undetectable viral load with CD4 count \<200 or not taking anti-retroviral medications. k) 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). 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 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 o) 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. 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (9 Sites)

University of Miami (Data Collection Only) — Miami, Florida
Dana Farber Cancer Institute — Boston, Massachusetts
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
Memorial Sloan Kettering Cancer Center — New York, New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York

📞 Contact the Study Coordinator

Phone: (646) 608-3726

Email: moskowia@mskcc.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All T-cell Lymphomas clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗