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

Recruiting now · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT02974647

Run by

Memorial Sloan Kettering Cancer Center

People needed

83

Starts

2016-11-01

Expected to finish

2027-11-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically confirmed T or NK cell lymphoma at the enrolling institution. For CTCL, patients with stage IB disease or greater are eligible.
• Relapse or refractory 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
• ECOG ≤ 2
• Measurable disease 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.
• Glucocorticoids 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 adjuvant and maintenance therapy for prior malignancy
• Patients must meet the following lab criteria:
• ANC ≥ 1.0/mm\^3 or ANC >/= 0.5/mm\^3 (if patient has baseline neutropenia due to lymphoma), platelets ≥ 100 x 10\^9/L or ≥ 50 x 10\^9/L (if related to lymphoma), Hgb ≥ 8g/dL
• Patients with LGL or T-PLL are not required to meet a minimum ANC or hemoglobin value for eligibility
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or; ≤ 3 x ULN if documented hepatic involvement with lymphoma, or ≤ 5 x ULN if history of Gilbert's ; AST and ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma involvement
• Creatinine clearance ≥ 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 hepatitis B core antibody or surface antigen, hepatitis B PCR must be negative and prophylaxis with entecavir or equivalent is required.
• Patients with HIV are allowed provided that they are on anti-retroviral treatment with no active infections.

You may not qualify if…

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• ECOG performance status >2
• Prior therapy with ruxolitinib
• Receiving systemic 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
• Adjuvant 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 reproductive potential† 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 postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).

Where it is running

• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (enrolling)
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Commack — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
• Northwestern Medicine (Data collection and specimen analysis) — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Miami — Miami, Florida, United States
• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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