Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia
NCT ID: NCT05592015
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2023-05-03
2025-12-31
Brief Summary
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Detailed Description
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I. Determine the overall response rate (ORR) of ruxolitinib in patients with T-cell large granular lymphocytic leukemia (T-LGLL) as compared to historical controls.
SECONDARY OBJECTIVES:
I. Rate of conversion from PR at 4 months to CR at 8 and 12 months (at full ruxolitinib dosage).
II. Rate of molecular remission (T-cell receptor \[TCR\] clearance, STAT3 mutation clearance) at 4, 8, 12 months.
III. Incidence of grade III/IV toxicities (at full ruxolitinib dosage). IV. Quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Health Assessment Questionnaire Disability Index (HAQDi), and Short Form (SF)-36 questionnaire at baseline, 5 months, and every 6 months during response follow up for up to 12 months.
EXPLORATORY OBJECTIVE:
I. Objective benefit (OB) rate at 4 months defined as a patient that had improvement in their cytopenias, transfusion dependence but not attaining a partial response (PR).
II. Leukemia-free survival III. Progression-free survival
OUTLINE:
Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients who achieve a response (CR or PR) may receive an additional 12 months of ruxolitinib, for a maximum of 24 months. Additionally, patients undergo blood sample collection throughout study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (ruxolitinib)
Patients receive ruxolitinib PO BID on days 1-28. Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients who achieve a response (CR or PR) may receive an additional 12 months of ruxolitinib, for a maximum of 24 months.
Ruxolitinib
Given PO
Interventions
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Ruxolitinib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Jonathan Brammer
OTHER
Responsible Party
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Jonathan Brammer
Principal Investigator
Principal Investigators
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Jonathan Brammer, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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The Ohio State University Comprehensive Cancer Center
Role: CONTACT
Phone: 800-293-5066
Email: [email protected]
Facility Contacts
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Eric Jacobsen, MD
Role: primary
Jillian Foreman
Role: backup
Alison Moskowitz, MD
Role: primary
Jonathan Brammer, MD
Role: primary
Related Links
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The Jamesline
Other Identifiers
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NCI-2022-02385
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-21336
Identifier Type: -
Identifier Source: org_study_id