Actively Recruiting
Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia
Led by Jonathan Brammer · Updated on 2026-02-10
30
Participants Needed
3
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests whether ruxolitinib works to shrink tumors in patients with T-cell large granular lymphocyte leukemia. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official 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 confirmed by specific cell population counts and presence of clonal T-cell receptor within 1 month of diagnosis or relapse
- Untreated or previously treated T-LGLL patients who have failed at least one frontline therapy
- Off treatment for at least 14 days or 5 half-lives before starting study drug
- Require treatment due to symptomatic anemia, transfusion-dependent anemia, or neutropenia with recurrent infections
- Platelet count above 50,000/uL, with transfusions allowed to maintain this level
- Renal function adequate with creatinine clearance of 90 mL/min or higher
- Serum creatinine no more than twice the upper limit of normal
- Liver enzymes (AST, ALT, ALP) within 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times upper limit of normal (patients with Gilbert's syndrome allowed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Men and women of reproductive potential agree to use effective birth control during study and until 5 half-lives after treatment ends
- Able to provide informed consent
You will not qualify if you...
- Absolute neutrophil count less than 100/mm3
- Active infection requiring antimicrobial treatment
- Positive HIV, hepatitis B surface antigen, or hepatitis C antibody
- Risk factors for tuberculosis without negative test results
- Concurrent immune-suppressive therapy except low-dose prednisone under specific conditions
- Active concurrent malignancy not related to T-LGLL
- Positive pregnancy test or breastfeeding in females of childbearing potential
- Unstable angina or recent myocardial infarction within 2 months
- Active exacerbation of lung diseases such as COPD or interstitial lung disease
- Cirrhosis
- Use of strong CYP3A4 inhibitors without appropriate washout period
- Consumption of grapefruit, Seville orange juice, pomelos, or starfruits within 14 days before and during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Lily Yang
CONTACT
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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