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Not recruiting
Phase 1
Phase 2

Azacitidine

Sponsor:

Jonathan Brammer

Code:

NCT05141682

Conditions

T-Cell Large Granular Lymphocyte Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Azacitidine

Study Details

Brief summary:

This phase I/II trial studies the best dose, possible benefits and/or side effects of oral azacitidine in treating patients with T-cell large granular lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions

T-Cell Large Granular Lymphocyte Leukemia

Study ID

NCT05141682

Start date

Jun 29, 2022

Status verified date

Jun, 2025

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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). 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 an LGL cell population >500 cells/mm3 and the presence of a clonal T-cell receptor within 1 month of diagnosis or relapse. 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

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (Oral Azacitidne)

Patients will receive CC-486 orally (PO) D1-14 of a 28-day cycle, in a similar fashion to the QUAZAR study for a minimum of 4 cycles. Patients that achieve a response (CR or PR) will remain on study for a maximum of 12 months. Patients without a response at 4 months will come off the study.

Interventions

Oral Azacitidine

Given PO

Primary outcome measure

  • Maximum tolerated dose of oral azacitidine (CC-486) (Phase I) [ Time Frame: Up to 4 cycles (1 cycle = 28 days) ]
  • Overall response rate (complete response [CR] + partial response [PR]) (Phase II) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jonathan Brammer, MD

614-366-6963Jonathan.Brammer@osumc.edu

Principal Investigator:

Jonathan Brammer, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Enrica Marchi, MD, PhD

em5yt@uvahealth.org

Principal Investigator:

Enrica Marchi, MD, PhD

More Information

Sponsor

Jonathan Brammer

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Jonathan Brammer on 2025-06-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.