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Ruxolitinib for T-Cell Large Granular Lymphocytic Leukemia

This study is testing a drug called ruxolitinib to see if it can shrink tumors in people with T-cell large granular lymphocytic leukemia (T-LGLL). Ruxolitinib works by blocking certain enzymes that cancer cells need to grow. To join, you must be at least 18 years old, able to swallow pills, and have a confirmed diagnosis of T-LGLL, which involves specific levels of certain cells in your blood. The main goal is to see how many patients respond to ruxolitinib within 12 months. This study is currently recruiting about 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Participants will take ruxolitinib by mouth twice daily for 28-day cycles. Treatment may continue for up to 24 months, with quality of life surveys at specific time points.
Compensation
Not stated in the trial record.
Follow-up
Overall response is measured for up to 12 months. Quality of life is assessed for up to 12 months during response follow-up.

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NCT05592015

Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia

Recruiting
PHASE2Ages 18+InterventionalTreatment
Jonathan Brammer
~30 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:Ruxolitinib

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Up to 12 months

Conditions

T-Cell Large Granular Lymphocyte Leukemia

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T-Cell Large Granular Lymphocyte LeukemiaCD3 ComplexCD57 AntigenCD8B wt AlleleT-Cell Receptor Alpha Chain

Where it's being run

3 sites across 3 states
Massachusetts1
New York1
Ohio1

Study leadership

  • Jonathan Brammer, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Eligibility criteria

Inclusion

Age 18 or older and able to swallow pills
Diagnosis of T-LGLL defined as: LGL cell population meeting diagnostic criteria (defined as CD3+CD8+ cell population \>650/mm3 or CD3+CD8+CD57+ population \>500/mm3 or LGL cell population with other immunophenotype that includes co-expression of CD3+, CD8+, CD57+ with \>500 cells/mm3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis or relapse). This also includes patients with rare T-LGLL variants include CD4+ T-LGLL, and gamma/delta T-LGLL which can be CD4- and CD8-), though patients still must have the presence of a clonal T-cell receptor within 1 month of diagnosis or relapse. Note: patients with MDS-like T-LGLL may be included with PI approval even if CD3+CD8+ cell population is \< 650/mm\^3, though +TCR is required. Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with \> 500 cells/mm\^3
Untreated T-LGLL or failed at least one line of frontline therapy;
Patients must be off treatment for at least 14 days or 5 half-lives, whichever is longer
Require Treatment for T-LGLL (one or more required)
Symptomatic anemia with hemoglobin \< 10 g/dL
Transfusion-dependent anemia
Neutropenia with absolute neutrophil count (ANC) \< 500/mm\^3
Neutropenia with ANC \< 1500/mm\^3 with recurrent infections
Serum creatinine =\< 2 x the upper limit of normal (ULN)
\- Estimated glomerular filtration rate (eGFR) =\> 30 mL/min using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subjects Body Surface Area \[BSA\])
Total bilirubin =\< 1.5 x ULN (patients with Gilbert's syndrome with a bilirubin \> 1.5 x ULN permitted)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
Alkaline phosphatase (ALP) =\< 2.5 x ULN
Eastern cooperative oncology group (ECOG) performance status =\< 2
Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study treatment until 5 half-lives have passed. Male subject agrees to use an acceptable method for contraception for the duration of the study treatment until 5 half-lives have passed.
Able to sign informed consent
Active infection requiring ongoing anti-microbial treatment. Patients with human immunodeficiency virus (HIV), positive hepatitis B surface antigen or hepatitis C antibody will be excluded. Patients with tuberculosis risk factors will be required to undergo quantiferon testing and/or purified protein derivative (PPD) testing with a negative result prior to entering the study.
Concurrent immune-suppressive therapy (prednisone or equivalent up to 20 mg permitted to treat LGLL symptoms, but must be weaned within one month of initiation of trial drug). Patients on stable, chronic prednisone =\< 10 mg for rheumatologic/autoimmune conditions are exempted from this requirement. They may enroll on the study
Active, concurrent malignancy unless deemed related to T-LGLL by principal investigator (PI). Early stage skin cancers, prostate cancer, permitted if under no active therapy
For females of childbearing potential: Positive pregnancy test or lactating
Unstable angina or myocardial infarction within the past 2 months
Chronic obstructive pulmonary disease or other interstitial lung disease in active exacerbation
Cirrhosis
For any strong CYP3A4 inhibitors deemed a moderate or severe risk of interaction with ruxolitinib, a wash-out period of 14 days, or 5 half-lives, whichever is longer, is needed prior to starting ruxolitinib
Given the CYP3A4 inhibition potential of grapefruit, grapefruit juice, Seville orange juice, pomelos, and starfruits, patients will need to refrain from these foods/drinks for 14 days prior to initiation of therapy, and throughout the study period

What this trial measures

  • Overall response rate (ORR)Up to 12 months

    The ORR will be calculated as the proportion of patients who achieve a response to therapy divided by the total number of evaluable patients. An evaluable patient is defined as an eligible patient who has received at least four months of therapy with ruxolitinib. All evaluable patients will be included in calculating the ORR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that the number of patients who respond is binomially distributed). Additional outcomes including rates of conversion from PR at 4 months to CR at 8 and 12 months on full dose ruxolitinib, and rate of molecular remission (TCR clearance, STAT3 mutation clearance) at 4, 8, 12 months on full dose ruxolitinib will also be reported as proportions with 95% binomial CIs.