MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT to Predict Patients at High Risk of Relapse

Study Overview
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Brief Summary
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A study on the Effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse

Detailed Description
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This is a retrospective and multicenter clinical study.This study is indicated for patients with hematological malignancies who underwent allo-HSCT. It aims to evaluate the effectiveness of digital droplet PCR in monitoring measurable residual disease during the early period after allogeneic hematopoietic stem cell transplantation to predict patients at high risk of relapse. 192 patients will be enrolled. The clinical end points include cumulative incidence of relapse, relapse-free survival, non-relapse mortality, and overall survival.

Official Title
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Measurable Residual Disease Monitoring by Digital Droplet PCR in the Early Period After Allogeneic Hematopoietic Stem Cell Transplantation to Predict Patients at High Risk of Relapse

Conditions
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Measurable Residual Disease

Intervention / Treatment
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* Diagnostic Test: Digital Droplet PCR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of at least one haematological tumour-associated mutation or fusion gene detected at diagnosis by NGS or real-time qPCR provided for posttransplant MRD monitoring; Successful stem cell engraftment Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT; Age 12-70 Exclusion Criteria: Patients who relapsed or died before the first ddPCR monitoring; Patients with only germline mutations.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ddPCR MRD positivity<br> | Diagnostic Test: Digital Droplet PCR<br>* Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period<br>|
| ddPCR MRD negativity<br> | Diagnostic Test: Digital Droplet PCR<br>* Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of relapse (CIR) | The time from the date of transplantation to disease recurrence: Disease recurrence, defined as one of the following: Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions. | At Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival (RFS) | The time from the date of treatment to the occurrence of any of the following: Death from any cause Disease recurrence | At Year 2 | 
| Non-relapse mortality (NRM) | Assessment of NRM at Year 2 | At Year 2 | 
| Overall survival (OS) | Assessment of OS at Year 2 | At Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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droplet digital PCR, allogeneic hematopoietic stem cell transplantation, relapse