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Completed

NCT Number: NCT06000306

MRD Monitoring by Digital Droplet PCR in the Early Period After Allo-HSCT 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

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Key information

Conditions

Measurable Residual Disease Disease Attributes Neoplasm, Residual Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Digital Droplet PCR

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relapse-free survival (RFS)

    Time frame: At Year 2

    The time from the date of treatment to the occurrence of any of the following:

    • Death from any cause
    • Disease recurrence

  2. Non-relapse mortality (NRM)

    Time frame: At Year 2

    Assessment of NRM at Year 2

  3. Overall survival (OS)

    Time frame: At Year 2

    Assessment of OS at Year 2

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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