Oral azacitidine treatment for relapsed or refractory T-cell leukemia
A Phase I/II Clinical Trial Evaluating CC-486 in Patients with Relapsed/Refractory T-Cell Large Granular Lymphocytic Leukemia (T-LGLL)
This study is testing if taking a new oral medication called azacitidine can help people with relapsed or stubborn T-cell leukemia feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | prednisone, Chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05141682 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial evaluates the safety and effectiveness of oral azacitidine in patients with relapsed or refractory T-cell large granular lymphocytic leukemia (T-LGLL). The study aims to determine the maximum tolerated dose and overall response rate of the treatment. Participants will receive azacitidine orally for 14 days in a 28-day cycle, with the possibility of extending treatment based on their response. The trial also assesses secondary outcomes such as progression-free survival and molecular remission rates.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with symptomatic T-LGLL who have failed at least one line of frontline therapy.
Not a fit: Patients with early-stage T-LGLL or those who have not yet undergone any treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with T-LGLL who have not responded to previous therapies.
How similar studies have performed: While there have been studies on azacitidine for other conditions, this specific approach for T-LGLL is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Diagnosis of T-LGLL defined as: CD3+CD8+ cell population \> 650/mm\^3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis). Note: patients with myelodysplastic syndrome (MDS)-like T-LGLL may be included with principal investigator (PI) approval even if CD3+CD8+ cell population is \< 650/mm\^3, though +TCR is required. Natural-killer (NK) large granular lymphocytic leukemia (LGL) is also permitted, provided there is a clonal NK-cell population noted with \> 500 cells/mm\^3 * Failed at least one line of frontline therapy; 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 * Serum creatinine =\< 2 x the upper limit of normal (ULN) * 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) =\< 1.5 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. Male subject agrees to use an acceptable method for contraception for the duration of the study * Able to sign informed consent Exclusion Criteria: * 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 PI * Prior use of 5-azacytidine or decitabine * Positive pregnancy test
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Brammer, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.