NCT06211166

Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction

Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.

Detailed description

This prospective clinical study focuses on patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions post-allogeneic hematopoietic stem cell transplantation. The primary objective is to assess the efficacy of digital Polymerase Chain Reaction (dPCR) in monitoring measurable residual disease (MRD), including markers such as BCR::ABL, KMT2A, etc., as compared to other MRD monitoring methods such as conventional quantitative PCR or multicolor Flow Cytometry (MFC). Key endpoints include the recurrence of MRD using conventional methods, hematological relapse, disease-free survival, overall survival, and non-relapse mortality.

Conditions

• Acute Leukemia
• MDS
• MDS/MPN
• CML

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Digital PCR	digital Polymerase Chain Reaction (dPCR)
DIAGNOSTIC_TEST	Quantitative PCR	Real-time Polymerase Chain Reaction (real-time PCR)
DIAGNOSTIC_TEST	MFC	Multicolor Flow Cytometry

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: China