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

• Sponsor: Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06000306
• Collaborator: (none)
• Enrollment: 192
• Location: 1
• Actual Duration (Months): 66.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Measurable Residual Disease	Diagnostic Test: Digital Droplet PCR

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 Design

• Study Type: Observational
• Actual Enrollment: 192 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official 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
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Relapse-free survival (RFS) [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) [At Year 2]

   Assessment of NRM at Year 2

3. Overall survival (OS) [At Year 2]

   Assessment of OS at Year 2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 70 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Hospital of Zhejiang Medical Colleage Zhejiang University	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: He Huang, The President of The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang University
• ClinicalTrials.gov Identifier: NCT06000306
• Other Study ID Numbers: IIT20230588C-R1
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by He Huang, The President of The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang University: droplet digital PCR; allogeneic hematopoietic stem cell transplantation; relapse
• Additional relevant MeSH terms: Neoplasm, Residual; Recurrence

Study Results

No Results Posted as of Aug 22, 2023