Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality

NCT06370000 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: MCC-23-20817HM20029540
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  The number of participants that complete at least four cycles of protocol therapy

  4 months

Secondary Outcomes (3)

• Overall survival (OS)

  3 months, and up to 2 years

• Leukemia Free Survival (LFS) 3 months after beginning of treatment and at relapse, completion of treatment or removal from study

  3 months, and up to 2 years

• Measure rates of measurable residual disease (MRD) negativity

  3 months, and up to 2 years

Study Arms (1)

Oral Azacitidine

EXPERIMENTAL

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

Drug: Oral Azacitidine

Interventions

Oral Azacitidine DRUG

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

Oral Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Keri Maher, DO

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)