Clinical trial · Observational
Development and Application of a Novel Digital Array PCR for Acute Myeloid Leukemia (AML)
LCCC 2103: Development and Application of a Novel Digital Array PCR Assay for Evaluation of Minimal Residual Disease in Acute Myeloid Leukemia (AML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Resources related issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Minimal Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detection of AML Specific mutations from peripheral blood
- timeFrame
- 2 years
- description
- Signal intensity above negative control at mutation sites
Secondary outcomes (2)
- measure
- Proportion of AML patients with detectable mutations
- timeFrame
- 2 years
- description
- Fraction of screened AML patients whose disease has a mutation that detectable on the first generation mutation panel.
- measure
- Association between AML specific mutation and relapse at 6 months
- timeFrame
- 2 years
- description
- Positive signal intensity and relapse information from medical recordrelapse at any time after initial detection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available