Monitoring minimal residual disease in patients with acute myeloid leukemia or myelodysplastic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

  This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• Adding FHD-286 to low‑dose decitabine and venetoclax for adverse‑risk AML

  This trial tests whether adding FHD-286 to a low‑dose decitabine plus venetoclax regimen helps people with newly diagnosed adverse‑risk acute myeloid leukemia or AML that progressed after one prior therapy.

  Recruiting Phase 1 Montefiore Medical Center · The Bronx, New York · NCT07283094

• Prophylactic DLI-X to Prevent Leukemia Relapse After Transplant

  This first-in-human trial tests a prophylactic DLI-X approach to see if it can prevent relapse after matched sibling or haploidentical stem cell transplant in patients with acute leukemias and related blood disorders.

  Recruiting Phase 1 University of Arizona · Tucson, Arizona · NCT07254793

• Induction and consolidation using fludarabine, cytarabine, idarubicin, and venetoclax for acute myeloid leukemia

  This trial tests whether adding venetoclax to induction and consolidation chemotherapy (fludarabine, cytarabine, and idarubicin) helps adults 18–65 with newly diagnosed acute myeloid leukemia or high-blast myelodysplastic syndrome achieve deeper remissions than standard cytarabine/daunorubicin therapy.

  Recruiting Phase 2 OHSU Knight Cancer Institute · Portland, Oregon · NCT07228273

• RPT1G for adults with relapsed or refractory acute myeloid leukemia and high-risk MDS

  This study will test whether the drug RPT1G is safe and find the best dose for adults whose AML or high-risk MDS has come back or not responded to treatment.

  Recruiting at 2 sites Phase 1 Remedy Plan, Inc. · New York, New York and 1 other locations · NCT07107126

• FLAG‑Ida chemotherapy followed by reduced‑intensity total‑body irradiation and donor stem cell transplant for adults 60+ with adverse‑risk AML or other high‑grade myeloid cancers

  This trial tests whether FLAG‑Ida chemotherapy given immediately before lower‑intensity total‑body radiation and a donor stem cell transplant can improve outcomes for adults 60 and older with newly diagnosed adverse‑risk acute myeloid leukemia or similar high‑grade myeloid cancers.

  Recruiting Phase 2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT07046078

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.