Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether treatment with azacitidine pills after initial treatment is workable for adults with acute myeloid leukemia (AML), a blood cancer. It is for people whose AML is in remission, meaning signs of cancer have cleared, who are medically able to receive a donor stem cell transplant but face barriers to care.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, have finished initial AML treatment, and join within 4 months of finishing treatment.
- Have AML confirmed by testing, without the APL type or FLT3 gene changes. Be in remission, even if blood cell counts have not fully recovered.
- In first remission, have AML for which a donor transplant is considered, such as higher-risk AML or cancer still found by sensitive tests. People in later remissions may also qualify.
- Be medically able to receive a donor stem cell transplant, based on a doctor's judgment or a transplant health score of 5 or less.
- Face a health-related disadvantage, such as money problems, lack of caregiver support, trouble understanding health information, distance from care, lack of a donor, or substance use problems.
- Meet the study's kidney and liver test limits and have a daily activity score of 0–3, ranging from fully active to needing some help with self-care.
- Be able to take pills, without a gut condition that could keep the medicine from being absorbed. Be able and willing to understand and sign the consent form.
- Agree to effective birth control during treatment and afterward: at least 6 months after the last dose for women who can become pregnant, and at least 3 months for men.
Who can't join
- Have FLT3 gene changes or uncontrolled leukemia in the brain or spinal cord.
- Have had an allergic reaction to azacitidine or any of its ingredients, or have taken oral azacitidine before.
- Have had a stem cell transplant within 3 months before starting study treatment.
- Have an uncontrolled illness or infection.
- Be pregnant or breastfeeding, or plan to donate eggs during treatment or within 6 months after the last dose.
- Plan to donate sperm during treatment or within 3 months after the last dose.
- Be receiving treatment for another cancer, except skin cancer that can be removed.
- Have a medical, mental health, or social condition that the study doctor believes could raise your risk or make it hard to follow study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
VA
- Virginia Commonwealth University · Richmond, VA 23298Massey CTO Heme Team · Study contact · 804-628-6430 · MasseyHemMlg@vcu.eduKeri Maher, DO · Principal investigatorMore trials in Richmond