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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06000306

Enrollment

192

Registered

2023-08-21

Start date

2018-01-01

Completion date

2023-07-31

Last updated

2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measurable Residual Disease

Keywords

droplet digital PCR, allogeneic hematopoietic stem cell transplantation, relapse

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.

Interventions

DIAGNOSTIC_TESTDigital Droplet PCR

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Non-relapse mortality (NRM)	At Year 2	Assessment of NRM at Year 2
Overall survival (OS)	At Year 2	Assessment of OS at Year 2

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026