Maintenance Therapy for Leukemia

(PREeMPT Trial)

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

SA

Sameem Abedin, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with a myeloid blood cancer or related disorder.
* Immunophenotypic assessment by flow for aberrant blasts
* NGS to identify persistence of malignant clones using a standard clinically available assay
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Assessment

Patients undergo usual disease assessments including immunophenotypic and/or molecular testing to determine MRD status

2 weeks

Transplantation

Patients undergo allogeneic hematopoietic cell transplantation (HCT)

1 week

Post-Transplant Maintenance Therapy

MRD positive patients may receive maintenance therapy based on MRD status

Variable

Follow-up

Participants are monitored for relapse-free survival with standard histological analysis of bone marrow biopsies

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Maintenance Therapy
  • No intervention

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: MRD positiveActive Control1 Intervention
Group II: MRD negativeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+