Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloid Disorders, Myeloproliferative Neoplasm
Conditions
Keywords
Allogeneic hematopoietic cell transplantation, Measurable residual disease
Brief 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.
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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 consent document, and the willingness to sign it.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with relapse-free survival | One Year | 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. |
Countries
United States
Contacts
CONTACTMedical College of Wisconsin Cancer Center Clinical Trials Office
PRINCIPAL_INVESTIGATORSameem Abedin, MD
Medical College of Wisconsin
Outcome results
None listed