Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML

Recruiting

• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
• Interventions: Other: MFC for the determination of leukemia stem cell

• Registration Number: NCT06452732
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Study Start: 2024-11-01
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 283

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRD monitoring	MFC for the determination of leukemia stem cell	-

Primary Outcome Measures

Name	Time	Method
The primary end point was cumulative incidences of relapse (CIR)	2 years	Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of diagnosis to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.

Secondary Outcome Measures

Name	Time	Method
Transplant related mortality (TRM)	2 years	Transplant-related mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.
Non-relapse mortality (NRM)	2 years	Non-relapse mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after CR.
Chronic GVHD	2 years	Chronic GVHD was defined and graded according to the National Institute of Health criteria:\[Biol Blood Marrow Transplant,2005,11: 945\] that is, mild cGVHD reflects the involvement of no more than 1 or 2 organs/sites (except for lung) with a maximum score of 1; moderate cGVHD involves at least 1 organ/site with a score of 2 or ≥3 organs/sites with a score of 1 (or lung score 1); and severe cGVHD is diagnosed when a score of 3 is given to any organ (or lung score 2). The diagnosis is mainly based on clinical manifestations.
Overall survival (OS)	2 years	Overall survival referred to patients who survived until the final follow-up time point.
Leukemia free survival (LFS)	2 years	Leukimia-free survival was defined as days from diagnosis to disease progression after transplantation.
Acute GVHD	2 years	Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement\[Sullivan KM. Graft-versus-host-disease. In: Thomas ED, Blume KG, Forman SJ (eds). Hematopoietic Cell Transplantation. 2nd edn. Blackwell Science: Boston, MA, USA, 1999, pp 515-536.\]; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut.

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China