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

Zhejiang University

Status: Completed

Conditions: Measurable Residual Disease

Treatments: Diagnostic Test: Digital Droplet PCR

Study type: Observational

Funder types: Other

Identifiers

NCT06000306

IIT20230588C-R1

Details and patient eligibility

About

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

Full description

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.

Enrollment: 192 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Successful stem cell engraftment
3. Received at least one bone marrow MRD detection by ddPCR in +30 days to +120 days after HSCT;
4. Age 12-70

Exclusion criteria

1. Patients who relapsed or died before the first ddPCR monitoring;
2. Patients with only germline mutations.

Trial design

192 participants in 2 patient groups

ddPCR MRD positivity

Treatment:

Diagnostic Test: Digital Droplet PCR

ddPCR MRD negativity

Treatment:

Diagnostic Test: Digital Droplet PCR