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

Recruiting

• Conditions: MDS/MPN; MDS; CML; Acute Leukemia
• Interventions: Diagnostic Test: Digital PCR; Diagnostic Test: Quantitative PCR; Diagnostic Test: MFC

• Registration Number: NCT06211166
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-08
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring.
• Neutrophil engraftment
• Received at least one MRD monitoring by digital PCR after HSCT

Exclusion Criteria

• Patients who relapsed or died before the first digital PCR monitoring
• Patients only with mutations in DNMT3A, TET2, and ASXL1 ("DTA mutations") or only germline mutations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDS or MDS/MPN	MFC	Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm
Acute Leukemia	Quantitative PCR	Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
Acute Leukemia	MFC	Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
MDS or MDS/MPN	Digital PCR	Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm
CML	Digital PCR	Chronic Myeloid Leukemia
Acute Leukemia	Digital PCR	Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
MDS or MDS/MPN	Quantitative PCR	Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm
CML	Quantitative PCR	Chronic Myeloid Leukemia

Primary Outcome Measures

Name	Time	Method
Threshold of dPCR to predict conventional MRD	2-year	To establish an optimal threshold for digital PolyTo establish an optimal threshold for digital Polymerase Chain Reaction (dPCR) in predicting Measurable Residual Disease (MRD) recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT). MRD recurrence is defined as the reappearance or elevation of minimal residual disease, as assessed by other MRD monitoring methods such as conventional quantitative PCR or multi-color Flow Cytometry (MFC), which served as indications of pre-emptive intervention by current consensus or guideline.

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of relapse (CIR)	2-year	The interval from the transplantation date to hematological recurrence
Overall survival (OS)	2-year	The time from HSCT to the Death from any cause
Relapse-free survival (RFS)	2-year	The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence
Non-Relapse Mortality(NRM)	2-year	The time from the date of HSCT to deaths that result from complications other than a relapse of the underlying disease.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China