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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07572929
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • No intervention — OTHER
    Patients will receive no maintenance therapy.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Feb 1, 2034
Completion
Feb 1, 2034

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MRD positive
    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.
  • Active Comparator: MRD negative
    MRD negative patients assigned to Arm B will receive no intervention.

Primary Outcome Measure

Number of subjects with relapse-free survival [ Time Frame: One Year ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Sameem Abedin, MD
[email protected]
414-805-4600
Sameem Abedin, MD (PRINCIPAL_INVESTIGATOR)

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