Monitoring residual disease in leukemia patients after stem cell transplantation
Official title: Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD
Run by Peking University People's Hospital · NCT06211166 · Data updated 2026-11-12
This study is testing a new digital method to see if it can better track leftover leukemia cells in patients after they receive a stem cell transplant compared to older methods.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 8, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | January 18, 2024 |
| Trial ID | NCT06211166 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with leukemia or myelodysplastic syndromes who have undergone allogeneic hematopoietic stem cell transplantation and have detectable genetic markers.
✕Probably not a fit
Patients who have relapsed or died before the first digital PCR monitoring or those with specific mutations that do not qualify for the study may not benefit.
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 investigates the effectiveness of digital Polymerase Chain Reaction (dPCR) for tracking measurable residual disease (MRD) in patients with leukemia and related conditions following allogeneic hematopoietic stem cell transplantation. The study aims to compare dPCR with traditional MRD monitoring techniques such as quantitative PCR and multicolor Flow Cytometry. Key outcomes include the detection of MRD, rates of hematological relapse, and overall survival metrics. The research focuses on patients who have specific genetic markers associated with their disease.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict relapse in leukemia patients, leading to improved monitoring and treatment strategies.
How similar studies have gone: While the use of dPCR for MRD monitoring is gaining traction, this specific approach in the context of allogeneic HSCT is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.
* Neutrophil engraftment
* Received at least one MRD monitoring by digital PCR after HSCT
Exclusion Criteria:
* Patients who relapsed or died before the first digital PCR monitoring
* Patients only with mutations in DNMT3A, TET2, and ASXL1 ("DTA mutations") or only germline mutations
Where it's running
-
Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Xiao-jun Huang, M.D — Peking University People's Hospital
- Study coordinator: Meng Lv, M.D,Ph.D
- Email: drlvmeng@163.com
- Phone: +861088324637
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.