Study on Oral Azacitidine for Transplant-Eligible Patients with Acute Myeloid Leukemia Facing Health Inequality

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT06370000

Provider View

This clinical trial is exploring the use of oral azacitidine as a maintenance treatment for patients with Acute Myeloid Leukemia (AML) who are eligible for a transplant but face health inequalities. The study aims to see if this approach is feasible and effective.

Patient Parameters

Program Overview

The study is testing whether taking oral azacitidine can be a practical and effective maintenance treatment for patients with Acute Myeloid Leukemia (AML) who are eligible for a transplant but face challenges such as financial difficulties, lack of support, or limited access to healthcare. The trial will assess how well the treatment works, its safety, and any side effects in these patients.

Description

This study is a pilot trial conducted at a single institution, where all participants will receive oral azacitidine. The goal is to see if this medication can be safely and effectively used as a maintenance treatment for patients with Acute Myeloid Leukemia (AML) who are eligible for a transplant but face health inequalities. These inequalities might include financial issues, lack of caregiver support, or difficulties accessing healthcare. The study will focus on patients who have completed their initial treatment and are in remission but are not able to proceed with a transplant due to these challenges. Researchers will monitor the patients for any side effects and evaluate how well the treatment helps in maintaining their remission.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-Acute Promyelocytic Leukemia (APL) FLT3 negative AML and in complete remission after initial treatment.
  • Considered for a transplant in first complete remission (CR1) if the disease is intermediate or high risk, or in second remission (CR2) and beyond for any AML type except FLT3+ and APL.
  • Medically eligible for a transplant based on doctor's assessment or specific health index.
  • Aged 18 years or older.
  • Enrolled within 4 months after completing initial therapy.
  • Identified health disparity in one of the CDC's social determinants of health, such as financial issues or lack of healthcare access.
  • Adequate organ function, including kidney and liver function.
  • ECOG performance status of 0 to 3, indicating varying levels of activity.
  • Able to take oral medications.
  • No history of conditions that affect absorption of oral medications.
  • Women of childbearing potential must agree to use effective birth control during and for 6 months after treatment.
  • Men must agree to use effective birth control during and for 3 months after treatment.
  • Willing to sign informed consent and follow study requirements.

Exclusion Criteria

  • Have a specific genetic mutation (FLT3 ITD or TKD).
  • Have uncontrolled cancer spread to the brain or spinal cord.
  • Have allergies to azacitidine or its ingredients.
  • Have had a stem cell transplant within the last 3 months.
  • Have uncontrolled illness or infection.
  • Have previously been treated with oral azacitidine.
  • Women who are pregnant or plan to donate eggs during or after the study.
  • Men who plan to donate sperm during or after the study.
  • Have another cancer that is currently being treated, except for certain skin cancers.
  • Have any condition that might increase risk or affect participation in the study.

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23298RichmondVirginia

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