Actively Recruiting
A Phase II Study Evaluating the Efficacy of Ruxolitinib in Patients With T-Cell Large Granular Lymphocytic Leukemia
Led by Jonathan Brammer · Updated on 2026-02-10
30
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ruxolitinib for patients with T-cell large granular lymphocyte leukemia (T-LGLL), a type of cancer affecting certain white blood cells. This phase II trial aims to determine how well ruxolitinib can shrink tumors and improve blood cell counts compared to historical results. The study also looks at safety, quality of life, and molecular changes over time in people living with this leukemia. Participants take ruxolitinib orally twice a day in 28-day cycles for up to 12 months, as long as the disease does not worsen and side effects remain acceptable. Those who respond to the treatment may continue for another 12 months, with a maximum treatment period of 24 months. Blood samples are collected throughout to monitor the disease and treatment effects. During the study, participants will have regular assessments including blood tests, quality of life questionnaires, and monitoring for side effects. The main goal is to measure the overall response rate within 12 months. Secondary goals include evaluating survival without leukemia progression and changes in quality of life over the same period. Participants are followed closely to track their health and treatment outcomes.
CONDITIONS
Brief Title
Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older and able to swallow pills
- Diagnosis of T-LGLL with specific cell population and clonal T-cell receptor within 1 month of diagnosis or relapse
- Untreated or previously treated T-LGLL with at least one line of frontline therapy failed
- Off previous treatment for at least 14 days or 5 half-lives, whichever is longer
- Require treatment for T-LGLL including symptomatic anemia, transfusion-dependent anemia, or neutropenia with recurrent infections
- Platelet count above 50 x 10^9/L; platelet transfusion allowed to meet this criterion
- Serum creatinine less than or equal to 2 times upper limit of normal
- Estimated glomerular filtration rate (eGFR) of 30 mL/min or higher
- Total bilirubin less than or equal to 1.5 times upper limit of normal (Gilbert's syndrome allowed)
- AST and ALT less than or equal to 2.5 times upper limit of normal
- Alkaline phosphatase less than or equal to 2.5 times upper limit of normal
- ECOG performance status 0 to 2
- Men and women of reproductive potential must agree to use accepted birth control methods during treatment
- Able to sign informed consent
You will not qualify if you...
- Absolute neutrophil count less than 100/mm^3
- Active infection requiring ongoing antimicrobial treatment
- Positive HIV, hepatitis B surface antigen, or hepatitis C antibody
- Tuberculosis risk factors without negative test results
- Concurrent immune-suppressive therapy above allowed prednisone dose unless stable for autoimmune conditions
- Active, concurrent malignancy unless related to T-LGLL
- Positive pregnancy test or lactating in females of childbearing potential
- Unstable angina or myocardial infarction within past 2 months
- Active exacerbation of chronic obstructive pulmonary disease or other lung diseases
- Cirrhosis
- Use of strong CYP3A4 inhibitors without appropriate washout
- Consumption of grapefruit or related juices 14 days prior to and during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive ruxolitinib orally twice daily in 28-day cycles for 12 months unless disease progresses or toxicity occurs. Those who respond may continue treatment for up to 24 months.
Monthly visits during treatment cycles
Duration - Up to 12 months
Participants are monitored for response, adverse events, and quality of life up to 12 months after starting treatment.
Visits at baseline, 5 months, and every 6 months during follow-up
Trial Site Locations
Total: 3 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
L
Lily Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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