Leukemia stem cell test to predict relapse and survival in AML with MLL rearrangement.
Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia
This project will test if measuring leukemia stem cells in people aged 6–60 with AML and MLL rearrangement can predict relapse and survival.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 6 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07537738 on ClinicalTrials.gov |
What this trial studies
This observational study will measure leukemia stem cells by multiparameter flow cytometry in bone marrow samples collected at the same times patients undergo routine minimal residual disease (MRD) testing. Participants are people aged 6–60 with AML and documented MLL rearrangement who are receiving chemotherapy or undergoing allogeneic hematopoietic stem cell transplantation. The presence and level of leukemia stem cells will be correlated with relapse rates and overall survival to determine their predictive value. All testing is performed at Peking University People's Hospital using clinical sample schedules to minimize additional procedures.
Who should consider this trial
Good fit: People aged 6–60 with acute myeloid leukemia and documented MLL rearrangement who are receiving chemotherapy or planning/undergoing allogeneic stem cell transplant and can provide bone marrow samples.
Not a fit: Patients without MLL rearrangement, those outside the 6–60 age range, or those unable to undergo bone marrow sampling or receive standard chemotherapy/allo‑SCT are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this test could identify patients at higher risk of relapse so doctors can intensify monitoring or tailor treatment earlier.
How similar studies have performed: Prior work using leukemia stem cell detection and flow‑based MRD has shown promise for predicting relapse in AML overall, but focused data specifically for MLL‑rearranged cases remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Acute myeloiud leukemia patients with MLL arrangement aging 6-60 years recieving chemoterapy or allo-geneic hematopoietic stem cell transplantation. Exclusion Criteria: 1. Patients who cannot recieve chemoterapy or allo-geneic hematopoietic stem cell transplantation. 2. Patients who cannot comply with the study.
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Siqi Li, PhD
- Email: tina_li_1995@163.com
- Phone: +86 18611944638
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.