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

NCT07572929 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: PRO00058929
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloid Disorders; Myelodysplastic Syndromes; Myeloproliferative Neoplasm; Acute Myeloid Leukemia

Keywords

Allogeneic hematopoietic cell transplantation; Measurable residual disease

Outcome Measures

Primary Outcomes (1)

• Number of subjects with relapse-free survival

  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.

  One Year

Study Arms (2)

MRD positive

ACTIVE COMPARATOR

MRD positive patients assigned to Arm A are required to initiate maintenance therapy on this study. Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.

Drug: Maintenance Therapy

MRD negative

ACTIVE COMPARATOR

MRD negative patients assigned to Arm B will receive no intervention.

Other: No intervention

Interventions

Maintenance Therapy DRUG

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

MRD positive

No intervention OTHER

Patients will receive no maintenance therapy.

MRD negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myeloproliferative Disorders; Leukemia, Myeloid, Acute; Neoplasm, Residual

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Sameem Abedin, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2034
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)