Monitoring minimal residual disease in patients with acute myeloid leukemia or myelodysplastic syndrome
A Program for Monitoring Minimal Residual Disease Following Treatment of Patients With Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome
This study is trying to see if new tests can help find hidden cancer cells in patients with acute myeloid leukemia or myelodysplastic syndrome who seem to be in remission, to better understand their risk of relapse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT01311258 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop assays that assess the impact of therapy on patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS). It focuses on identifying minimal residual disease (MRD) in patients who appear to be in remission but may still harbor malignant cells that could lead to relapse. By utilizing specialized assays that target specific proteins on the surface of these malignant cells, the study seeks to improve the understanding of disease relapse risk in AML and MDS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are being evaluated for AML or high-grade MDS and have not undergone recent cytotoxic therapy.
Not a fit: Patients with serious medical or psychiatric illnesses that limit their ability to participate in the study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of relapse risk in patients with AML and MDS, potentially improving treatment strategies.
How similar studies have performed: Other studies have shown promise in identifying minimal residual disease in similar patient populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael W Becker, MD — University of Rochester
- Study coordinator: Michael W Becker, MD
- Email: Michael_Becker@URMC.Rochester.edu
- Phone: 585-273-3968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.