Study on Ruxolitinib for Treating T-Cell Large Granular Lymphocytic Leukemia

Sponsor: Jonathan Brammer

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05592015

Provider View

This clinical trial is testing whether the drug ruxolitinib can help shrink tumors in patients with T-cell large granular lymphocytic leukemia by blocking certain enzymes that cancer cells need to grow.

Patient Parameters

Program Overview

The purpose of this phase II study is to find out if ruxolitinib can effectively reduce tumors in patients with T-cell large granular lymphocytic leukemia (T-LGLL). Ruxolitinib works by blocking enzymes that are important for cancer cell growth.

Description

The main goal of this study is to see how well ruxolitinib works in treating T-cell large granular lymphocytic leukemia (T-LGLL) compared to past treatments. Researchers will look at how many patients have a complete or partial response to the drug, how long these responses last, and how long patients stay free of leukemia. They will also check if patients' conditions improve from partial to complete response over time and if there is a reduction in specific cancer markers. The study will monitor any serious side effects and assess patients' quality of life using questionnaires.

Patients will take ruxolitinib by mouth twice a day in 28-day cycles for up to 12 months, as long as the disease does not worsen and side effects are manageable. If patients respond well, they may continue treatment for another 12 months, up to a total of 24 months.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • Diagnosed with T-LGLL, with specific cell counts and markers
  • Untreated T-LGLL
  • Have tried at least one previous treatment and stopped it at least 14 days ago
  • Need treatment for T-LGLL due to:
    • Anemia with low hemoglobin
    • Anemia requiring blood transfusions
    • Low neutrophil count with or without infections
  • Platelet count above 50,000
  • Normal kidney and liver function within specified limits
  • Good overall health with a performance status of 2 or less
  • Agree to use birth control during the study
  • Able to provide informed consent

Exclusion Criteria

  • Very low neutrophil count
  • Active infection needing treatment
  • HIV, hepatitis B, or hepatitis C positive
  • Taking immune-suppressing drugs, except for low-dose prednisone
  • Other active cancers, unless related to T-LGLL
  • Positive pregnancy test
  • Low platelet count
  • Recent heart problems
  • Severe lung disease
  • Abnormal liver or kidney function beyond specified limits

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