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 trial investigates the effectiveness of a personalized approach to maintenance therapy for individuals with certain blood cancers, such as leukemia, following a stem cell transplant. The goal is to determine if treatment decisions based on measurable residual disease (MRD) can improve outcomes. If doctors detect leftover cancer cells, participants may receive additional therapy. This trial suits those diagnosed with myeloid blood cancers or similar conditions who are undergoing a stem cell transplant. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that maintenance therapy for some types of leukemia is often well-tolerated. For example, one study found that patients taking an oral form of this therapy had a 74.5% survival rate after 12 months. This indicates that many people can manage the treatment and continue with it. However, earlier studies found that some patients experienced too many side effects without clear benefits. Thus, while some patients do well with this therapy, others may encounter more problems.

Further research on specific maintenance therapies has shown mixed results regarding their safety and effectiveness. Some therapies have been linked to better survival rates, while others still raise concerns about side effects. Although the data is promising, individual responses to these treatments can vary.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores maintenance therapy options based on a patient's MRD (minimal residual disease) status, which is a new approach to treating leukemia. Unlike standard treatments that apply the same protocols to all patients, this method tailors therapy based on whether patients are MRD positive or negative. This personalized approach could lead to more effective treatments with potentially fewer side effects, as it allows doctors to decide the best course of action based on the patient's specific condition. Additionally, the trial highlights the potential to better manage leukemia by focusing on the residual disease, which is often a predictor of relapse.

What evidence suggests that this trial's treatments could be effective for leukemia?

Research has shown that ongoing treatment, known as maintenance therapy, can help patients with acute myeloid leukemia (AML) live longer and reduce the chance of cancer returning. In this trial, MRD-positive patients will receive maintenance therapy. One study found that patients who received maintenance therapy lived for an average of 37.8 months, compared to 15.5 months for those who did not. Another study reported that after 12 months, 72.8% of patients on maintenance therapy were still alive, compared to 55.8% of those who took a placebo. Additionally, maintenance therapy helped patients stay cancer-free for an average of 19 months, compared to 12 months without it. These findings support using maintenance therapy to help prevent relapse and extend the lives of AML patients.12678

Who Is on the Research Team?

SA

Sameem Abedin, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) with certain blood cancers like acute myeloid leukemia, myelodysplastic syndrome, or related disorders who are about to have a stem cell transplant. Participants must be able to understand and sign consent forms.

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

Trial Overview

The study checks if using test results before transplant can help decide who should get extra maintenance therapy after their stem cell transplant to prevent cancer from coming back. Some patients will get maintenance therapy based on these results; others won't.

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+

Citations

Maintenance therapy in AML: A meta-analysis and a single ...

Maintenance therapy is a potential strategy to improve prognosis and prolong remission durations for AML, but continues to be a subject of ...

Maintenance therapy in acute myeloid leukemia - PMC - NIH

With these advances, outcomes in AML have improved but remains far from satisfactory. One approach towards preventing relapse in AML is to use maintenance ...

Outcomes with intensive treatment for acute myeloid ...

The median OS time increased significantly from 15.5 months (95% confidence interval [95% CI]: 13.8-17.6) to 37.8 months (95% CI: 31.6-49.2) ...

Real‐world treatment patterns and outcomes with oral ...

For OS rates at 12 months, the estimated survival rates were 72.8% and 55.8% with oral-AZA and placebo, respectively. The AML disease landscape ...

Post-HCT maintenance therapy for AML: who, when, why, ...

... outcomes, this review focuses on the data (or lack thereof) directly supporting this practice, as well as some of the pitfalls that can be ...

Real-World Analysis of Oral Chemotherapy Dose ...

Several observational studies have assessed the correlation between low ANC or WBC and a reduced risk for relapse during maintenance therapy with mixed results.

Therapeutic ANC attainment during maintenance ...

The primary outcome was the cumulative percentage of time spent within a target ANC range of 500-1,500 cells/μL after the start of maintenance ...

Maintenance therapy in AML: Treatment options and clinical ...

We discuss the role, therapeutic options, and clinical considerations of a maintenance strategy in the treatment of AML.