RECRUITING

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

Conditions

T-Cell Large Granular Lymphocyte Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-03

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05592015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 or older and able to swallow pills * Diagnosis of T-LGLL defined as: CD3+CD8+ cell population \> 650/mm\^3 or CD3+CD8+CD57+ population \> 500/mm\^3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis). 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	* Absolute neutrophil count (ANC) less than 100/mm\^3 * 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 * Concurrent immune-suppressive therapy (prednisone or equivalent up to 20 mg permitted to treat T-LGL 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

Inclusion Criteria

Exclusion Criteria

* Age 18 or older and able to swallow pills
* Diagnosis of T-LGLL defined as: CD3+CD8+ cell population \> 650/mm\^3 or CD3+CD8+CD57+ population \> 500/mm\^3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis). 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

* Absolute neutrophil count (ANC) less than 100/mm\^3
* 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
* Concurrent immune-suppressive therapy (prednisone or equivalent up to 20 mg permitted to treat T-LGL 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

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Lily Yang

CONTACT

614-293-6191

lily.yang@osumc.edu

Principal Investigator

Jonathan Brammer, MD

PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Jonathan Brammer

Jonathan Brammer, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-03

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-05-03

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

T-Cell Large Granular Lymphocyte Leukemia