Acute Myeloid Leukemia
Conditions
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
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.
Interventions
DRUGOral Azacitidine
Oral Azacitidine, 300mg PO Daily during days 1-14 of a 28 day cycle for up to 6 cycles.
Sponsors
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4 months | The number of participants that complete at least four cycles of protocol therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 3 months, and up to 2 years | Number of participants alive at relapse, completion of treatment or removal from study. |
| 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 | Number of participants still in remission 3 months after beginning of treatment and at relapse, completion of treatment or removal from study |
| Measure rates of measurable residual disease (MRD) negativity | 3 months, and up to 2 years | The number of participants that have negative measurable residual disease (MRD) at 3 months after beginning of treatment, and completion of treatment. MRD will be measured by flow cytometry and by pathologic complete response (PCR) based molecular assay if/when target gene is available on diagnostic specimen. |
| Assess whether such an approach may provide an effective bridge to curative intent allogeneic hematopoietic stem cell transplant (alloHCT) | Up to 2 years | Number of patients who successfully move on to receive an allogeneic hematopoietic stem cell transplant (alloHCT). |
Countries
United States
Contacts
CONTACTMassey IIT Research Operations
PRINCIPAL_INVESTIGATORKeri Maher, DO
Virginia Commonwealth University
Outcome results
None listed