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Monitoring Minimal Residual Disease in AML and High-Grade MDS

This study is looking at ways to detect very small amounts of cancer cells, called Minimal Residual Disease (MRD), in people with Acute Myeloid Leukemia (AML) or high-grade Myelodysplastic Syndrome (MDS). Researchers want to see if these new tests can predict who is more likely to have their cancer come back after treatment. You may be able to join if you are being evaluated for or treated for AML or high-grade MDS, and haven't had certain chemotherapy treatments in the last three months. The study aims to identify MRD after treatment, with results measured at 2 years. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 400 participants. It is not testing a specific drug or intervention.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 2 years, suggesting participants will be followed for at least that long after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01311258

Monitoring Minimal Residual Disease of Patients With Acute Myelogenous Leukemia or High Grade Myelodysplastic Syndrome

Recruiting
Not specifiedAges 18+Observational
University of Rochester
~400 participants
Updated 2025-09-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of Minimal Residual Disease after treatment for disease
Measured over 2 years

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndrome

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Michael W Becker, MD · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Michael W Becker, MD
[email protected]
585-273-3968
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Are being evaluated for the diagnosis and/or treatment of Acute Myelogenous Leukemia or High Grade myelodysplastic syndrome (defined as greater than 10 percent blasts on examination of the bone marrow aspirate).
Have not undergone prior cytotoxic therapy for acute myelogenous leukemia or High Grade myelodysplastic syndrome in the past 3 months other than hydroxyurea or Revlimid.
Have not previously received an allogeneic peripheral blood or bone marrow stem cell transplant for their disease.
Are able to sign an informed consent. Informed consent must be signed at the time of enrollment and prior to the collection of any specimens and/or clinical data (other than PHI needed to screen and identify patients, which will be promptly discarded in a secure fashion if patient is not enrolled on study)
Are at least 18 years of age.
Do not have any serious medical or psychiatric illness, other than that treated by this study which would limit the ability of the patient to receive therapy or give informed consent.
Have been informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

Exclusion

Subjects who are less than 18 years of age.
Subjects with limited decision making capacity.
Subjects who have received prior cytotoxic therapy, other than hydroxyurea or Revlimid, for their disease within the past three months.
Patients with a diagnosis of chronic myelogenous leukemia in blast crisis, Acute Promyelocytic Leukemia, or Bi-lineage leukemia.
Subjects who have previously undergone an allogeneic peripheral blood stem cell transplant.
Have an active malignancy other than acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) at the time of evaluation or a prior history of treatment for a malignancy other than AML or MDS within the past 2 years.

What this trial measures

  • Identification of Minimal Residual Disease after treatment for disease2 years

    To test the ability to identify Minimal Residual Disease following therapy by performing special assays that specifically target this minor population of malignant cells by evaluating the expression of cell surface antigens previously shown to be informative.