Monitoring Minimal Residual Disease Following Treatment of Patients With Acute Myeloid Leukemia (AML) or High Grade Myelodysplastic Syndrome (MDS) (MRD)
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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 |
- 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 2015 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
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 |
Hematology/oncology clinic
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| 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 |
| 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 | |
| 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: | November 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rochester:
|
AML MDS |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasm, Residual Neoplasms by Histologic Type |
Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013