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

Last updated: September 10, 2025
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Platelet Disorders

Anemia

Treatment

N/A

Clinical Study ID

NCT01311258
20123
  • Ages > 18
  • All Genders

Study Summary

This study is being performed to develop assays to determine the impact of the therapy patients receive for treatment of AML or MDS and to determine if these tests can identify those patients who are at a greater risk for having their disease relapse.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are being evaluated for the diagnosis and/or treatment of Acute Myelogenous Leukemiaor High Grade myelodysplastic syndrome (defined as greater than 10 percent blasts onexamination of the bone marrow aspirate).

  • Have not undergone prior cytotoxic therapy for acute myelogenous leukemia or HighGrade myelodysplastic syndrome in the past 3 months other than hydroxyurea orRevlimid.

  • Have not previously received an allogeneic peripheral blood or bone marrow stem celltransplant for their disease.

  • Are able to sign an informed consent. Informed consent must be signed at the time ofenrollment and prior to the collection of any specimens and/or clinical data (otherthan PHI needed to screen and identify patients, which will be promptly discarded ina 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 bythis study which would limit the ability of the patient to receive therapy or giveinformed consent.

  • Have been informed of the investigational nature of this study and given writteninformed consent in accordance with institutional and federal guidelines.

Exclusion

Exclusion Criteria:

  • 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 orRevlimid, for their disease within the past three months.

  • Patients with a diagnosis of chronic myelogenous leukemia in blast crisis, AcutePromyelocytic Leukemia, or Bi-lineage leukemia.

  • Subjects who have previously undergone an allogeneic peripheral blood stem celltransplant.

  • Have an active malignancy other than acute myelogenous leukemia (AML) ormyelodysplastic syndrome (MDS) at the time of evaluation or a prior history oftreatment for a malignancy other than AML or MDS within the past 2 years.

Study Design

Total Participants: 400
Study Start date:
August 01, 2007
Estimated Completion Date:
August 31, 2030

Study Description

Following therapy, the majority of patients with AML and many patients with MDS will achieve a remission that is defined by the lack of any evidence of the disease when viewing bone marrow samples under a microscope. Despite the absence of disease by this method, many patients in remission will still have what is referred to as Minimal Residual Disease when more sensitive methods are applied. The presence of Minimal Residual Disease following therapy does not guarantee that the patient will experience a relapse. This is likely a result of the failure of these techniques to examine those cells that are responsible for disease relapse. Recent data suggests that in the majority of patients with AML or MDS only a minor population of the malignant cells are capable of maintaining the disease and are likely responsible for relapse following therapy. This minor population of cells can be identified by the proteins they have on their surface. This study tests the ability to identify Minimal Residual Disease following therapy by performing special assays that specifically target this minor population of malignant cells.

Connect with a study center

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Active - Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

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