Recruiting

Azacitidine

Sponsor:

Virginia Commonwealth University

Code:

NCT06370000

Conditions

Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oral Azacitidine

Study Details

Brief summary:

Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains

Conditions

Acute Myeloid Leukemia

Study ID

NCT06370000

Start date

Nov 7, 2024

Status verified date

May, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed non-Acute Promyelocytic (APL) FLT3 negative AML and have completed induction and consolidation as defined by the treating physician and must be in complete response (CR), Complete response with partial hematologic recovery (CRh), or Complete response with incomplete count recovery (CRi) at time of study enrollment
  • For patients in CR1, AML disease phenotype must be one that is considered for allo HCT in CR1 (intermediate or high risk by European Leukemia Net (ELN), MRD+ CR, slow clearance of MRD) or any AML phenotype (aside from FLT3+ and APL) in CR2 and beyond
  • Medically eligible for allogeneic hematopoietic cell transplant (allo HCT) as defined by either: treating physician discretion, transplant physician discretion, or hematopoietic cell transplantation-specific Comorbidity index (HCT-CI) index of 5 or less
  • Age ≥ 18 years
  • Enrollment must occur within 4 months of completion of therapy
  • A patient or staff identified health disparity in 1 of the 5 Centers for Disease Control (CDC) defined social determinants of health (SDOH). This may include financial difficulties, lack of caregiver support, difficulties with medical literacy, rurality, appropriate access to health care, lack of an appropriate allogeneic hematopoietic cell transplant (allo HCT) donor, substance abuse
  • Patient must have adequate organ function defined as: Creatinine clearance (by Cockroft-Gault formula) greater than or equal to 29 mL/min, total bilirubin and aspartate aminotransferase/ alanine transaminase (AST/ALT) ≤ to institutional 2x upper limit of normal (except Gilbert's syndrome, which may enroll if < 2x patient's baseline total bilirubin)
  • Eastern Cooperative Oncology Group (ECOG) 0,1,2,3
  • Ability to take oral medications
  • No history of malabsorption syndrome which, in the investigator's opinion, may inhibit absorption of oral medications
  • Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Women who are breastfeeding are also excluded
  • Male patients must consent to effective contraception during study and at least 3 months after last dose
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria A patient who meets any of the following exclusion criteria is ineligible to participate in the study.

  • FMS-like tyrosine kinase 3 (FLT3 ITD) or tyrosine kinase domain (TKD) mutation
  • Uncontrolled central nervous system (CNS) involvement
  • History of hypersensitivity or allergic reaction to azacitidine or its components
  • Stem cell transplant within previous 3 months prior to initiation of study therapy
  • Uncontrolled intercurrent illness or infection
  • History of prior therapy with oral azacitidine
  • Female patients who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
  • Male patients who intend to donate sperm during the course of this study or for 3 months after last dose
  • Other malignancy for which the patient is currently receiving therapy (except excisable skin cancer)
  • Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Oral Azacitidine

Starting dose is oral azacitidine 300 mg orally once daily with or without food days 1-14 in a 28-day cycle

Interventions

Oral Azacitidine

Oral Azacitidine, 300mg PO Daily during days 1-14 of a 28 day cycle for up to 6 cycles.

Primary outcome measure

  • Rate of completion of at least 4 cycles an oral maintenance strategy for transplant eligible AML patients in CR who are medically underserved or have a disadvantage in the CDC SDOH domains [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Massey IIT Research Operations

804-628-6430masseyepd@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Keri Maher, DO

More Information

Sponsor

Virginia Commonwealth University

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-05-29.