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

NCT ID: NCT06211166

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Acute Leukemia MDS MDS/MPN CML

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Leukemia

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

Digital PCR

Intervention Type DIAGNOSTIC_TEST

digital Polymerase Chain Reaction (dPCR)

Quantitative PCR

Intervention Type DIAGNOSTIC_TEST

Real-time Polymerase Chain Reaction (real-time PCR)

MFC

Intervention Type DIAGNOSTIC_TEST

Multicolor Flow Cytometry

MDS or MDS/MPN

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

Digital PCR

Intervention Type DIAGNOSTIC_TEST

digital Polymerase Chain Reaction (dPCR)

Quantitative PCR

Intervention Type DIAGNOSTIC_TEST

Real-time Polymerase Chain Reaction (real-time PCR)

MFC

Intervention Type DIAGNOSTIC_TEST

Multicolor Flow Cytometry

CML

Chronic Myeloid Leukemia

Digital PCR

Intervention Type DIAGNOSTIC_TEST

digital Polymerase Chain Reaction (dPCR)

Quantitative PCR

Intervention Type DIAGNOSTIC_TEST

Real-time Polymerase Chain Reaction (real-time PCR)

Interventions

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Digital PCR

digital Polymerase Chain Reaction (dPCR)

Intervention Type DIAGNOSTIC_TEST

Quantitative PCR

Real-time Polymerase Chain Reaction (real-time PCR)

Intervention Type DIAGNOSTIC_TEST

MFC

Multicolor Flow Cytometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Jun Huang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-jun Huang, M.D

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Meng Lv, M.D,Ph.D

Role: CONTACT

+861088324637

Ya-zhen Qin, Ph.D

Role: CONTACT

+861088324702

Facility Contacts

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Zi-qi Han, BS

Role: primary

+861088324577

Other Identifiers

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2021PHA154-001

Identifier Type: -

Identifier Source: org_study_id

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