Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)

Stopped early

Conditions studied: Leukemia, Myeloid, Acute, Minimal Residual Disease

In brief

Purpose: The purpose of this trial is to investigate whether a digital array assay can detect trace amounts of residual leukemia and predict relapse in acute myeloid leukemia (AML) patients in remission who have undergone allogeneic stem cell transplantation (SCT) at the North Carolina Cancer Hospital (NCCH). Participants: Adult patients (18 years of age or older) with diagnosed AML who are going to undergo stem cell transplant (SCT). Procedures (methods): A total of 10 eligible subjects will be treated per standard of care with SCT. Peripheral blood and bone marrow aspirate (10 mL each) for digital array assay analysis will be collected along with routine lab draws and bone marrow biopsy procedures prior to SCT. Beginning 1 month after SCT peripheral blood (10 ml) will be collected to assess MRD by digital array assay analysis on a monthly basis for up to 6 months. In addition, bone marrow aspirate will be collected at approximately Month 3 and 6 following SCT for assay analysis. Patient medical records will be reviewed 6 and 12 months after completing their last MRD follow up assessment to confirm survival status, remission status, and gather information related to relapse.

Key facts

Study ID

NCT04920188

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

10

Starts

2021-05-28

Expected to finish

2024-05-25

Last updated by the study team

2024-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥18 years of age) diagnosed with AML who are going to undergo stem cell transplant (SCT). These subjects must provide written informed consent to participate.
• Subjects must have an identified mutation that has been validated on the multiplex daPCR assay.

You may not qualify if…

• Adult patients (≥18 years of age) diagnosed with AML who are scheduled to undergo SCT at the NCCH who do not provide written informed consent to participate are ineligible.

Where it is running

• North Carolina Cancer Hospital (NCCH) — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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