RECRUITING

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

Talk to us

Conditions

Acute Myeloid Leukemia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-07
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06370000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * 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
  4. * Age ≥ 18 years
  5. * Enrollment must occur within 4 months of completion of therapy
  6. * 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
  7. * 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)
  8. * Eastern Cooperative Oncology Group (ECOG) 0,1,2,3
  9. * Ability to take oral medications
  10. * No history of malabsorption syndrome which, in the investigator's opinion, may inhibit absorption of oral medications
  11. * 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
  12. * Male patients must consent to effective contraception during study and at least 3 months after last dose
  13. * Ability to understand and the willingness to sign a written informed consent document
  14. * FMS-like tyrosine kinase 3 (FLT3 ITD) or tyrosine kinase domain (TKD) mutation
  15. * Uncontrolled central nervous system (CNS) involvement
  16. * History of hypersensitivity or allergic reaction to azacitidine or its components
  17. * Stem cell transplant within previous 3 months prior to initiation of study therapy
  18. * Uncontrolled intercurrent illness or infection
  19. * History of prior therapy with oral azacitidine
  20. * 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
  21. * Male patients who intend to donate sperm during the course of this study or for 3 months after last dose
  22. * Other malignancy for which the patient is currently receiving therapy (except excisable skin cancer)
  23. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Kristin Lantis, RN
CONTACT
804-828-2177
kllantis@vcu.edu
Massey Heme Malig Team
CONTACT
MasseyHemMlg@vcu.edu

Principal Investigator

Keri Maher, DO
PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

  • Keri Maher, DO, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-07
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2024-11-07
Study Completion Date2029-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia