Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MFC for the determination of leukemia stem cell.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.
Interventions
- Other MFC for the determination of leukemia stem cell
MFC for the determination of leukemia stem cell
Primary outcome measures
- The primary end point was cumulative incidences of relapse (CIR) [Time frame: 2 years]
Secondary outcome measures (6)
- Leukemia free survival (LFS) [Time frame: 2 years]
- Overall survival (OS) [Time frame: 2 years]
- Non-relapse mortality (NRM) [Time frame: 2 years]
- Transplant related mortality (TRM) [Time frame: 2 years]
- Acute GVHD [Time frame: 2 years]
- Chronic GVHD [Time frame: 2 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Peking University People's Hospital — Beijing
- People's Hospital of Peking University — Beijing
Identifiers
NCT: NCT06452732 · PekingUPH Chang Ying-Jun