RECRUITING

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

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome AML MDS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Program for Monitoring Minimal Residual Disease Following Treatment of Patients with Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome

Quick Facts

Study Start:2007-08

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01311258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Michael W Becker, MD

PRINCIPAL_INVESTIGATOR

University of Rochester

Study Locations (Sites)

University of Rochester Medical Center

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Michael W Becker, MD, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-08

Study Completion Date2025-08

Study Record Updates

Study Start Date2007-08

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Acute Myeloid Leukemia
Myelodysplastic Syndrome