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New treatment option for T-Cell Large Granular Lymphocyte Leukemia
Official title Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT05592015
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for t-cell large granular lymphocyte leukemia.
Also referred to as INCB-18424, INCB18424.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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+...
- 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)
You likely can't join if
- Absolute neutrophil count (ANC) less than 100/mm\^3. Note: granulocyte colony-stimulating factor (G-CSF) may be utilized to enable patients to meet...
- Active infection requiring ongoing anti-microbial treatment. Patients with human immunodeficiency virus (HIV), positive hepatitis B surface antigen...
- Concurrent immune-suppressive therapy (prednisone or equivalent up to 20 mg permitted to treat LGLL symptoms, but must be weaned within one month of...
- Active, concurrent malignancy unless deemed related to T-LGLL by principal investigator (PI). Early stage skin cancers, prostate cancer, permitted if...
- For females of childbearing potential: Positive pregnancy test or lactating
- Unstable angina or myocardial infarction within the past 2 months
See the full eligibility 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...
- 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 , 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...
- 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 people Body Surface Area [BSA])
- Total 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...
- Able to sign informed consent
- 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...
- 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...
- 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 =\<...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- New York, New York, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; New York, New York, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.