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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Enrollment: 400 patients (estimated)

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Trial Locations

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New York

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