RecruitingPhase 2

Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia

A Phase II Study Evaluating the Efficacy of Ruxolitinib in Patients With T-Cell Large Granular Lymphocytic Leukemia (T-LGLL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Health Assessment Questionnaire Disability Index (HAQDi), and Short Form (SF)-36 questionnaire at baseline, 5 months, and every 6 months during response follow up for up to 12 months."
  • "Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity."
  • "Additionally, patients undergo blood sample collection throughout study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ruxolitinib can shrink tumors in adults with T-cell large granular lymphocytic leukemia (T-LGLL). The drug may block enzymes that cancer cells need to grow. People with certain related forms of this leukemia may also join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, able to swallow pills, and able to sign a form agreeing to join.
  • Have T-LGLL confirmed by required blood tests. Some rare forms and natural killer (NK) LGL leukemia are allowed.
  • Have had no treatment, or have had at least one first treatment fail. Stop prior treatment for at least 14 days, or longer if the drug stays in your body longer.
  • Need treatment because of low red blood cells causing symptoms or needing transfusions, or very low infection-fighting white blood cells.
  • Have more than 50,000 platelets per microliter of blood. Platelets help blood clot. Transfusions may help meet this rule, but the count must stay above this level for 5 days.
  • Meet the study’s kidney and liver blood test limits. People with both reduced kidney function and platelets below 100,000 cannot join.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • If able to have children, agree to use accepted birth control during treatment and for the required time afterward.

Who can't join

  • Have fewer than 100 infection-fighting white blood cells per cubic millimeter. Medicine to raise this count may be allowed if it stays above 100 for 5 days after the last dose.
  • Have an active infection needing ongoing treatment, HIV, or positive tests for hepatitis B or C. People at risk for tuberculosis must have negative tests.
  • Take medicines that weaken the immune system. Some prednisone use is allowed; doses for leukemia symptoms must be reduced and stopped within one month.
  • Have another active cancer, unless the study doctor considers it related to T-LGLL. Early skin cancers and prostate cancer may be allowed if not being treated.
  • Be pregnant or breastfeeding.
  • Have unstable chest pain from heart disease, a heart attack within the past 2 months, a current flare of certain lung diseases, or severe liver scarring called cirrhosis.
  • Take certain medicines that strongly affect how the body handles ruxolitinib without stopping them for at least 14 days, or longer if needed.
  • Have grapefruit, grapefruit juice, Seville orange juice, pomelos, or starfruit during the 14 days before treatment or during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 or older and able to swallow pills * Diagnosis of T-LGLL defined as: LGL cell population meeting diagnostic criteria (defined as CD3+CD8+ cell population \>650/mm3 or CD3+CD8+CD57+ population \>500/mm3 or LGL cell population with other immunophenotype that includes co-expression of CD3+, CD8+, CD57+ with \>500 cells/mm3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis or relapse). This also includes patients with rare T-LGLL variants include CD4+ T-LGLL, and gamma/delta T-LGLL which can be CD4- and CD8-), though patients still must have the presence of a clonal T-cell receptor within 1 month of diagnosis or relapse. Note: patients with MDS-like T-LGLL may be included with PI approval even if CD3+CD8+ cell population is \< 650/mm\^3, though +TCR is required. Natural-Killer (NK) LGL is also permitted, provided there is a clonal NK-cell population noted with \> 500 cells/mm\^3 * Untreated T-LGLL or failed at least one line of frontline therapy; * Patients must be off treatment for at least 14 days or 5 half-lives, whichever is longer * Require Treatment for T-LGLL (one or more required) * Symptomatic anemia with hemoglobin \< 10 g/dL * Transfusion-dependent anemia * Neutropenia with absolute neutrophil count (ANC) \< 500/mm\^3 * Neutropenia with ANC \< 1500/mm\^3 with recurrent infections * Platelet count \> 50 x 10\^9/L. Platelet transfusion may be utilized to meet inclusion criteria, as long as the platelet count remains \>50,000/uL within 5 days of last transfusion. Note: Patients with platelets \<100 x 109/L and renal impairment are not permitted to enroll to the study. Renal impairment is defined as creatinine clearance (CrCl) \< 90 mL/min. * Serum creatinine =\< 2 x the upper limit of normal (ULN) * \- Estimated glomerular filtration rate (eGFR) =\> 30 mL/min using the Modification of Diet in Renal Disease (MDRD) equation (multiplying eGFR by each subjects Body Surface Area \[BSA\]) * Total bilirubin =\< 1.5 x ULN (patients with Gilbert's syndrome with a bilirubin \> 1.5 x ULN permitted) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN * Alkaline phosphatase (ALP) =\< 2.5 x ULN * Eastern cooperative oncology group (ECOG) performance status =\< 2 * Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study treatment until 5 half-lives have passed. Male subject agrees to use an acceptable method for contraception for the duration of the study treatment until 5 half-lives have passed. * Able to sign informed consent Exclusion Criteria: * Absolute neutrophil count (ANC) less than 100/mm\^3. Note: granulocyte colony-stimulating factor (G-CSF) may be utilized to enable patients to meet inclusion criteria, as long as the ANC remains above 100/mm\^3 for 5 days after administration of last growth-factor. * Active infection requiring ongoing anti-microbial treatment. Patients with human immunodeficiency virus (HIV), positive hepatitis B surface antigen or hepatitis C antibody will be excluded. Patients with tuberculosis risk factors will be required to undergo quantiferon testing and/or purified protein derivative (PPD) testing with a negative result prior to entering the study. * Concurrent immune-suppressive therapy (prednisone or equivalent up to 20 mg permitted to treat LGLL symptoms, but must be weaned within one month of initiation of trial drug). Patients on stable, chronic prednisone =\< 10 mg for rheumatologic/autoimmune conditions are exempted from this requirement. They may enroll on the study * Active, concurrent malignancy unless deemed related to T-LGLL by principal investigator (PI). Early stage skin cancers, prostate cancer, permitted if under no active therapy * For females of childbearing potential: Positive pregnancy test or lactating * Unstable angina or myocardial infarction within the past 2 months * Chronic obstructive pulmonary disease or other interstitial lung disease in active exacerbation * Cirrhosis * For any strong CYP3A4 inhibitors deemed a moderate or severe risk of interaction with ruxolitinib, a wash-out period of 14 days, or 5 half-lives, whichever is longer, is needed prior to starting ruxolitinib * Given the CYP3A4 inhibition potential of grapefruit, grapefruit juice, Seville orange juice, pomelos, and starfruits, patients will need to refrain from these foods/drinks for 14 days prior to initiation of therapy, and throughout the study period

Study sites (3)

MA

NY

OH