Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05592015

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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