Detecting leukemia stem cells in blood and bone marrow to predict relapse in acute leukemia
Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in Pediatric Acute Myeloid Leukaemia: a Prospective Study
Peking University People's Hospital · NCT06452732
This study is testing if finding leukemia stem cells in the blood and bone marrow can help doctors predict relapses in children under 18 with acute leukemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 283 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06452732 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the prediction of relapse in patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) by using multiparametric flow cytometry to detect circulating leukemia stem cells. The study focuses on newly diagnosed patients under 18 years old who can provide informed consent. By identifying these stem cells, the researchers hope to enhance the accuracy of relapse predictions and potentially guide preemptive therapies. The study is being conducted at multiple centers, including Peking University People's Hospital.
Who should consider this trial
Good fit: Ideal candidates for this study are newly diagnosed patients with acute myeloid leukemia or acute lymphoblastic leukemia who are 18 years old or younger.
Not a fit: Patients with severe cardiac, liver, or kidney diseases, or those unable to comply with the study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of leukemia relapse, allowing for timely interventions that may improve patient outcomes.
How similar studies have performed: While the approach of using circulating leukemia stem cells for relapse prediction is promising, it is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnoses candidates with acute myeloid leukemia. * Lower than or equal to 18 years-old; * Subjects are able to provide written informed consent. Exclusion Criteria: * Subjects who cannot comply with the study; * Subjects with severe cardiac disease (ejection fraction\<50% ), liver disease (total bilirubin \>34umol/L, ALT and AST\>1.5×upper limit normal) or kidney disease (Serum creatinine\>130umol/L). * Subjects with severe infection. * Subjects with other conditions that cannot receive chemotherapy or transplantation.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)
- People's Hospital of Peking University — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Yingjun Chang Y Prof. Ying-Jun Chang Chang
- Email: rmcyj@bjmu.edu.cn
- Phone: 8610-88325949
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.
Conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia