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

ConditionsAcute LeukemiaMDSMDS/MPNCML
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD monitoring peri-HSCT

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Digital PCR

    Diagnostic test

    digital Polymerase Chain Reaction (dPCR)

  • Quantitative PCR

    Diagnostic test

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

  • MFC

    Diagnostic test

    Multicolor Flow Cytometry

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Acute Leukemia3 interventions
Group B: MDS or MDS/MPN3 interventions
Group C: CML2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2-year

Secondary outcomes

1

Cumulative incidence of relapse (CIR)

The interval from the transplantation date to hematological recurrence

Time frame
2-year
2

Overall survival (OS)

The time from HSCT to the Death from any cause

Time frame
2-year
3

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

Time frame
2-year
4

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.

Time frame
2-year

Other outcomes

Sponsors and contacts

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Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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