This is a prospective, open-label investigation to determine whether measurable residual disease (MRD) guided assignment of maintenance therapy is effective in patients with myeloid malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Pre-HCT, patients will undergo usual disease assessments which should include immunophenotypic and/or molecular testing. Based on the results of these tests, patients may or may not be recommended to receive maintenance therapy post-transplant, depending on the presence or absence of a residual malignant clone.
Age ≥18 years at time of transplant.
Must have a diagnosis of a myeloid malignancy, myelodysplastic syndrome, myeloproliferative neoplasm (including primary or secondary myelofibrosis), or acute myeloid leukemia or biphenotypic acute leukemia.
Immunophenotypic assessment by flow for aberrant blasts
NGS to identify persistence of malignant clones using a standard clinically available assay
None
Parallel
Maintenance Therapy
DrugMaintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.
No intervention
Other interventionPatients will receive no maintenance therapy.
Number of subjects with relapse-free survival
All patients will have standard histological analysis of bone marrow biopsies done post-transplant after engraftment, per institutional standard, at one year. For acute leukemia (AML or ALL) or myelodysplastic syndrome, relapse is defined as greater than 5% blasts on histologic analysis of bone marrow biopsy. Among patients assigned to Arm B, institution of any therapy with intent to treat hematologic malignancy will also be considered evidence of relapse.
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