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NCT Number: NCT07572929

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

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.

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Key information

Conditions

Myeloid Disorders Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasm, Residual Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location contact

Sameem Abedin, MD

CONTACT

[email protected]

414-805-4600

Sameem Abedin, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maintenance therapy

Drug

Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.

No intervention

Other

Patients will receive no maintenance therapy.

Primary outcomes

  1. Number of subjects with relapse-free survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

[email protected]

866-680-0505 ext. 8900

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Acronym: PREeMPT

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
May 7, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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