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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452732
• Other study ID #: PekingUPH Chang Ying-Jun
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 283
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• MFC for the determination of leukemia stem cell
MFC for the determination of leukemia stem cell

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing 302 Hospital, The First Affiliated Hospital of Zhengzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point was cumulative incidences of relapse (CIR)	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.	2 years
Secondary	Leukemia free survival (LFS)	Leukimia-free survival was defined as days from diagnosis to disease progression after transplantation.	2 years
Secondary	Overall survival (OS)	Overall survival referred to patients who survived until the final follow-up time point.	2 years
Secondary	Non-relapse mortality (NRM)	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.	2 years
Secondary	Transplant related mortality (TRM)	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.	2 years
Secondary	Acute GVHD	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.	2 years
Secondary	Chronic GVHD	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.	2 years