Monitoring residual disease in leukemia patients after stem cell transplantation
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
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06211166 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.