REMAIN1: Relapse Prevention With Maintenance Oral Azacitidine in Transplant Eligible Patients With Acute Myeloid Leukemia Not Proceeding to Transplant Due to Racial or Socioeconomic Disparities
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
Detailed description
This is a non-randomized open-label single institution pilot study that will evaluate the feasibility, toxicity, and efficacy of maintenance oral azacitidine in medically transplant eligible non-FMS-like tyrosine kinase 3 (FLT3) mutated AML patients with a disadvantage in at least 1 of the 5 key Center for Disease Control and Prevention (CDC) defined social determinants of health (SDOH) domains that are preclusive to transplant at time of study enrollment, as identified either by the patient or a member of the healthcare team.
Arms & interventions
- DrugOral Azacitidine
Oral Azacitidine, 300mg PO Daily during days 1-14 of a 28 day cycle for up to 6 cycles.
Outcome measures
Primary
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
Time frame: 4 months
Secondary
Overall survival (OS)
Time frame: 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
Time frame: 3 months, and up to 2 years
Measure rates of measurable residual disease (MRD) negativity
Time frame: 3 months, and up to 2 years
Assess whether such an approach may provide an effective bridge to curative intent allogeneic hematopoietic stem cell transplant (alloHCT)
Time frame: Up to 2 years
Eligibility criteria
Study locations (1)
Virginia Commonwealth University
Richmond, Virginia, 23298