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

August 17, 2023 updated by: He Huang, Zhejiang University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Hospital of Zhejiang Medical Colleage Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD mornitoring in the early period of allo-HSCT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ddPCR MRD positivity
Diagnostic test: Digital Droplet PCR
Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period
ddPCR MRD negativity
Diagnostic test: Digital Droplet PCR
Measurable residual disease Monitoring by Digital Droplet PCR in the Early Posttransplant Period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of relapse (CIR)
Time Frame: 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.
At Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-relapse mortality (NRM)
Time Frame: At Year 2
Assessment of NRM at Year 2
At Year 2
Overall survival (OS)
Time Frame: At Year 2
Assessment of OS at Year 2
At Year 2
Relapse-free survival (RFS)
Time Frame: 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
At Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20230588C-R1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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