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

Acute Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211166
• Other study ID #: 2021PHA154-001
• Status: Recruiting
• Start date: January 8, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Peking University People's Hospital
• Contact: Meng Lv, M.D,Ph.D
• Phone: +861088324637
• Email: drlvmeng[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukemia
• CML
• MDS
• MDS/MPN
• Neoplasm, Residual

Intervention

Diagnostic Test:
• Digital PCR
digital Polymerase Chain Reaction (dPCR)
• Quantitative PCR
Real-time Polymerase Chain Reaction (real-time PCR)
• MFC
Multicolor Flow Cytometry

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Threshold of dPCR to predict conventional MRD	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.	2-year
Secondary	Cumulative incidence of relapse (CIR)	The interval from the transplantation date to hematological recurrence	2-year
Secondary	Overall survival (OS)	The time from HSCT to the Death from any cause	2-year
Secondary	Relapse-free survival (RFS)	The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence	2-year
Secondary	Non-Relapse Mortality(NRM)	The time from the date of HSCT to deaths that result from complications other than a relapse of the underlying disease.	2-year