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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is developing tests to see how well treatment works and who may be more likely to have their disease come back. It is for adults being checked or treated for acute myelogenous leukemia (AML), a blood cancer, or high-grade myelodysplastic syndrome (MDS), a serious bone marrow disease.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You are being checked or treated for AML or high-grade MDS. High-grade MDS means more than 10% of cells in a bone marrow sample are blasts (immature blood cells).
  • In the past 3 months, you have not had cell-killing treatment for AML or MDS, except hydroxyurea or Revlimid.
  • You have never had a transplant of blood or bone marrow stem cells from a donor to treat your disease.
  • You can understand the study and sign a consent form. You must sign when joining, before study samples or clinical data are collected, except information needed for screening.
  • You have no other serious medical or mental health illness that would limit your ability to receive treatment or give consent.

Who can't join

  • You are younger than 18.
  • You have limited ability to make decisions.
  • You had cell-killing treatment for your disease in the past 3 months, other than hydroxyurea or Revlimid.
  • You have chronic myelogenous leukemia in blast crisis (an advanced phase), acute promyelocytic leukemia, or bi-lineage leukemia (leukemia involving two cell types).
  • You have had a transplant of stem cells collected from a donor's blood.
  • You currently have a cancer other than AML or MDS, or you were treated for another cancer within the past 2 years.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

NY