Myeloid DisordersPhase 2PREeMPTNCT07572929
A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant
A Phase 2 study testing Maintenance Therapy in people with Myeloid Disorders and Myelodysplastic Syndromes, run by Medical College of Wisconsin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Disorders, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- What is being tested?
- Maintenance Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Feb 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sameem Abedin, MD, 414-805-4600, Sabedin@mcw.edu
Sameem Abedin, MD
About this study
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
- Being tested
- Maintenance Therapy, No intervention
- Keywords
- Allogeneic hematopoietic cell transplantation, Measurable residual disease
- Medical subject headings
- Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance TherapyDrug
Maintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician.
No interventionOther
Patients will receive no maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Maintenance Therapy |
| MRD negative | Active comparator | MRD negative patients assigned to Arm B will receive no intervention. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Feb 2034 (estimated)
- Study completion1 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid DisordersStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameem M. Abedin, MD, Medical College of Wisconsin
- Investigators
- Sameem Abedin, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572929
- Sponsor's protocol ID
- PRO00058929
- Acronym
- PREeMPT
- Status last verified
- Oct 2026
- First submitted
- 1 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant
- ClinicalTrials.gov ID
- NCT07572929
- Acronym / sponsor ID
- PREeMPT / PRO00058929
- Conditions
- Myeloid Disorders, Myelodysplastic Syndromes, Myeloproliferative Neoplasm, Acute Myeloid Leukemia
- Keywords
- Allogeneic hematopoietic cell transplantation, Measurable residual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Feb 2034 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRD positive | Active comparator | Drug: Maintenance TherapyMRD 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 | Active comparator | Other: No interventionMRD negative patients assigned to Arm B will receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintenance TherapyMaintenance therapy will be suggested by the PIs, however final choice of maintenance is at the discretion of the treating physician. | Drug | MRD positive |
| No interventionPatients will receive no maintenance therapy. | Other | MRD negative |
Primary outcome
Number of subjects with relapse-free survival
Time frame: One Year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Myeloid Disorders
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Sameem Abedin, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maintenance Therapy in people with Myeloid Disorders and Myelodysplastic Syndromes, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with relapse-free survival (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.