Recruiting

Observational Study

Sponsor:

University of Rochester

Code:

NCT01311258

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Study ID

NCT01311258

Start date

Aug, 2007

Status verified date

Sep, 2025

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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 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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Identification of Minimal Residual Disease after treatment for disease [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Michael W Becker, MD

585-273-3968Michael_Becker@URMC.Rochester.edu

Jamie Littleton, MSN,RN,CCRC

585-273-3150jamie_littleton@urmc.rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Michael W Becker, MD

585-273-3968Michael_Becker@URMC.Rochester.edu

Principal Investigator:

Michael W Becker, MD

More Information

Sponsor

University of Rochester

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • AML
  • MDS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-09-17.