Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older who are able to swallow pills
• People who have been diagnosed with T-cell Large Granular Lymphocytic Leukemia (T-LGLL), including rare types such as CD4+ T-LGLL and gamma/delta T-LGLL, confirmed by specific blood cell counts and a clonal T-cell receptor test within 1 month of diagnosis or relapse (confirm specific subtype eligibility with trial site)
• People with Natural Killer (NK) cell LGL, provided a clonal NK-cell population is confirmed at a level above 500 cells per cubic millimetre
• People who have either never been treated for T-LGLL, or who have tried at least one previous treatment that did not work
• People who have stopped any previous T-LGLL treatment for at least 14 days or five half-lives of that treatment, whichever is longer
• People who need treatment because of one or more of the following: low haemoglobin (below 10 g/dL), dependence on blood transfusions for anaemia, very low white blood cell counts (neutropenia) below 500/mm³, or neutropenia below 1,500/mm³ with recurring infections
• People with a platelet count above 50 x 10⁹/L (platelet transfusions may be used to meet this level, with conditions — confirm with trial site)
• People with kidney function meeting specific blood test thresholds (confirm exact values with trial site)
• People with liver function results within acceptable ranges on specific blood tests (confirm exact values with trial site)
• People who are generally well enough to carry out basic daily activities, as measured by a standard health performance scale (ECOG score of 2 or below)
• People who are willing to use reliable contraception throughout the study period and until a set time after the last dose, or who are post-menopausal or surgically sterilised
• People who are able to read and sign an informed consent form

Who may not be able to join:

• People with an extremely low white blood cell (neutrophil) count below 100/mm³, even after medical support (confirm with trial site)
• People with an active infection that requires ongoing antibiotic or antiviral treatment
• People who are HIV-positive, or who test positive for hepatitis B or hepatitis C
• People with risk factors for tuberculosis who do not have a negative tuberculosis test result before starting the study
• People currently using immune-suppressing medications, with some exceptions for low-dose steroids used for other conditions (confirm details with trial site)
• People with another active cancer, unless the trial site's principal investigator determines it is related to T-LGLL (early-stage skin cancers and certain prostate cancers not requiring active treatment may be permitted — confirm with trial site)
• People who are pregnant or breastfeeding
• People who have had unstable chest pain (angina) or a heart attack within the past 2 months
• People with chronic obstructive pulmonary disease (COPD) or other lung conditions that are currently causing active symptoms or getting worse
• People with cirrhosis (severe liver scarring)
• People taking certain medications that strongly affect how the study drug (ruxolitinib) is processed by the body, who have not completed a washout period of at least 14 days or five half-lives, whichever is longer (confirm specific medications with trial site)
• People who are unwilling or unable to avoid grapefruit, grapefruit juice, Seville orange juice, pomelos, and starfruit for at least 14 days before starting the study drug and throughout the entire study period

Important: Always verify eligibility with the trial site directly before applying.