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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical College of Wisconsin

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Maintenance Therapy
  • No intervention

Treatment groups

450 Participants
are divided into 2 treatment groups

Sponsors and collaborators