Monitoring Minimal Residual Disease Following Treatment of Patients With Acute Myeloid Leukemia (AML) or High Grade Myelodysplastic Syndrome (MDS) (MRD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Rochester
Sponsor:
Collaborators:
Ohio State University
Rochester General Hospital
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01311258
First received: March 7, 2011
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.


Condition
Acute Myeloid Leukemia
High Grade Myelodysplastic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Program for Monitoring Minimal Residual Disease Following Treatment of Patients With Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Identification of Minimal Residual Disease after treatment for disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: August 2007
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hematology/oncology clinic

Criteria

Inclusion Criteria:

  • Are being evaluated for the diagnosis and/or treatment of Acute Myelogenous Leukemia or High Grade MDS (defined as greater than 10 percent blasts on examination of the bone marrow aspirate).
  • Have not undergone prior cytotoxic therapy for AML or High Grade MDS in the past 3 months other than hydroxyurea or Revlamid.
  • 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 Revlamid, for their disease within the past three months.
  • Patients with a diagnosis of CML 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 AML or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311258

Contacts
Contact: Michael W Becker, MD 585-273-3968 Michael_Becker@URMC.Rochester.edu
Contact: Craig T Jordan, PhD 585-275-6339 Craig_Jordan@URMC.Rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Michael W Becker, MD    585-273-3968    Michael_Becker@URMC.Rochester.edu   
Contact: Craig T Jordan, PhD    585-275-6339    Craig_Jordan@URMC.Rochester.edu   
Principal Investigator: Michael W Becker, MD         
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Peter Kouides, MD    585-766-3980    peter.kouides@rochestergeneral.org   
Principal Investigator: Peter Kouides, MD         
Sponsors and Collaborators
University of Rochester
Ohio State University
Rochester General Hospital
Investigators
Principal Investigator: Michael W Becker, MD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01311258     History of Changes
Other Study ID Numbers: ULEU07047
Study First Received: March 7, 2011
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
AML
MDS

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease
Pathologic Processes
Neoplastic Processes

ClinicalTrials.gov processed this record on October 01, 2014