A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant
Medical College of Wisconsin
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 con…
Interventions
- DrugMaintenance Therapy
Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.
- OtherNo intervention
Patients will receive no maintenance therapy.
Location
- Froedtert & the Medical College of WisconsinMilwaukee, Wisconsin