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

Peking University

Status: Enrolling

Conditions: Acute Leukemia; CML; MDS/MPN; MDS

Treatments: Diagnostic Test: Digital PCR; Diagnostic Test: MFC; Diagnostic Test: Quantitative PCR

Study type: Observational

Funder types: Other

Identifiers

NCT06211166

2021PHA154-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Acute Leukemia

Description:

Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia

Treatment:

Diagnostic Test: Digital PCR

Diagnostic Test: Quantitative PCR

Diagnostic Test: MFC

MDS or MDS/MPN

Description:

Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm

Treatment:

Diagnostic Test: Digital PCR

Diagnostic Test: Quantitative PCR

Diagnostic Test: MFC

CML

Description:

Chronic Myeloid Leukemia

Treatment:

Diagnostic Test: Digital PCR

Diagnostic Test: Quantitative PCR