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

Zhejiang University192 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

192

Conditions

Measurable Residual Disease

Interventions

Digital Droplet PCRDIAGNOSTIC_TEST

Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: At Year 2

Secondary Outcomes

Relapse-free survival (RFS)

The time from the date of treatment to the occurrence of any of the following: 1. Death from any cause 2. Disease recurrence

Time frame: At Year 2

Non-relapse mortality (NRM)

Assessment of NRM at Year 2

Time frame: At Year 2

Overall survival (OS)

Assessment of OS at Year 2

Time frame: At Year 2

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.