A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maintenance Therapy, No intervention.
- Who it may be relevant to
- Registry conditions: Myeloid Disorders, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Maintenance Therapy
Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician. - Other No intervention
Patients will receive no maintenance therapy.
Primary outcome measures
- Number of subjects with relapse-free survival [Time frame: One Year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Froedtert & the Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07572929 · PRO00058929