What this study is
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.
What's being tested
- Maintenance Therapy
Intervention · DRUG
Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.
- No intervention
Intervention · OTHER
Patients will receive no maintenance therapy.
Study details
- Sponsor
- Medical College of Wisconsin
- Conditions
- Myeloid Disorders · Myelodysplastic Syndromes · Myeloproliferative Neoplasm · Acute Myeloid Leukemia
- Enrolling
- 450 people
- Starts
- 2026-12-01
- Est. completion
- 2034-02-01
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openFroedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
- Sameem Abedin, MD · Contact414-805-4600Sabedin@mcw.edu
- Sameem Abedin, MD · Principal investigator
Study team
Sponsor
Medical College of Wisconsin
Study ID PRO00058929
Principal investigator
Sameem Abedin, MD
Medical College of Wisconsin
CONTACT
Medical College of Wisconsin Cancer Center Clinical Trials Office
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.