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

NCT01311258 | Recruiting

• 1 other identifier: 20123
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

AML; MDS

Outcome Measures

Primary Outcomes (1)

• Identification of Minimal Residual Disease after treatment for disease

  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.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hematology/oncology clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood and bone marrow aspirate

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Officials

• Michael W Becker, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael W Becker, MD

CONTACT

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

Jamie Littleton, MSN,RN,CCRC

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 9, 2011
• Study Start: August 1, 2007
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)