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

Completed

• Conditions: Measurable Residual Disease
• Interventions: Diagnostic Test: Digital Droplet PCR

• Registration Number: NCT06000306
• Lead Sponsor: Zhejiang University

Brief Summary

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

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2021-08-31
• Study Completion: 2023-07-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-12
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ddPCR MRD negativity	Digital Droplet PCR	-
ddPCR MRD positivity	Digital Droplet PCR	-

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of relapse (CIR)	At Year 2	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.

Secondary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS)	At Year 2	The time from the date of treatment to the occurrence of any of the following: 1. Death from any cause; 2. Disease recurrence
Overall survival (OS)	At Year 2	Assessment of OS at Year 2
Non-relapse mortality (NRM)	At Year 2	Assessment of NRM at Year 2

Trial Locations

Locations (1)

The First Hospital of Zhejiang Medical Colleage Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China