Maintenance Therapy for Leukemia
(PREeMPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Sameem Abedin, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-Transplant Assessment
Patients undergo usual disease assessments including immunophenotypic and/or molecular testing to determine MRD status
Transplantation
Patients undergo allogeneic hematopoietic cell transplantation (HCT)
Post-Transplant Maintenance Therapy
MRD positive patients may receive maintenance therapy based on MRD status
Follow-up
Participants are monitored for relapse-free survival with standard histological analysis of bone marrow biopsies
What Are the Treatments Tested in This Trial?
Interventions
- Maintenance Therapy
- No intervention
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
MRD negative patients assigned to Arm B will receive no intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor
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