A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant

A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant

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.

Inclusion Criteria:

• 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.
• Pre-transplant disease assessment must include at least one:
• Immunophenotypic assessment by flow for aberrant blasts
• NGS to identify persistence of malignant clones using a standard clinically available assay
• PCR based measurement of prior identified mutations (if applicable)
• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

None