Acute LeukemiaNCT06211166
Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
An observational study of Acute Leukemia and MDS, run by Peking University People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Leukemia, MDS, MDS/MPN
- What is being tested?
- Digital PCR, Quantitative PCR and MFC
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD monitoring peri-HSCT
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Zi-qi Han, BS, +861088324577, ncrch_pku@163.com
Xiao-jun Huang
About this study
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
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.
Read the 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.
- Conditions
- Acute Leukemia, MDS, MDS/MPN, CML
- Being tested
- Digital PCR, Quantitative PCR, MFC
- Keywords
- dPCR, MRD, allo-HSCT, leukemia
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital PCRDiagnostic test
digital Polymerase Chain Reaction (dPCR)
Quantitative PCRDiagnostic test
Real-time Polymerase Chain Reaction (real-time PCR)
MFCDiagnostic test
Multicolor Flow Cytometry
| Study group | Role | What they receive |
|---|---|---|
| Acute Leukemia | Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia Receives: Diagnostic Test: Digital PCR; Diagnostic Test: Quantitative PCR; Diagnostic Test: MFC | |
| MDS or MDS/MPN | Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm Receives: Diagnostic Test: Digital PCR; Diagnostic Test: Quantitative PCR; Diagnostic Test: MFC | |
| CML | Chronic Myeloid Leukemia Receives: Diagnostic Test: Digital PCR; Diagnostic Test: Quantitative PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-year
Secondary outcomes (4)
Cumulative incidence of relapse (CIR)
The interval from the transplantation date to hematological recurrence
Measured: 2-year
Overall survival (OS)
The time from HSCT to the Death from any cause
Measured: 2-year
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
Measured: 2-year
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.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start8 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiao-jun Huang, M.D, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211166
- Sponsor's protocol ID
- 2021PHA154-001
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06211166
- Acronym / sponsor ID
- 2021PHA154-001
- Conditions
- Acute Leukemia, MDS, MDS/MPN, CML
- Keywords
- dPCR, MRD, allo-HSCT, leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Leukemia | – | Diagnostic Test: Digital PCR, Diagnostic Test: Quantitative PCR, Diagnostic Test: MFCAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia |
| MDS or MDS/MPN | – | Diagnostic Test: Digital PCR, Diagnostic Test: Quantitative PCR, Diagnostic Test: MFCMyelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm |
| CML | – | Diagnostic Test: Digital PCR, Diagnostic Test: Quantitative PCRChronic Myeloid Leukemia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD monitoring peri-HSCT
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital PCRdigital Polymerase Chain Reaction (dPCR) | Diagnostic test | Acute Leukemia, CML, MDS or MDS/MPN |
| Quantitative PCRReal-time Polymerase Chain Reaction (real-time PCR) | Diagnostic test | Acute Leukemia, CML, MDS or MDS/MPN |
| MFCMulticolor Flow Cytometry | Diagnostic test | Acute Leukemia, MDS or MDS/MPN |
Primary outcome
Threshold of dPCR to predict conventional MRD
Time frame: 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.
4 secondary outcomes
Cumulative incidence of relapse (CIR)
Time frame: 2-year
Overall survival (OS)
Time frame: 2-year
Relapse-free survival (RFS)
Time frame: 2-year
Non-Relapse Mortality(NRM)
Time frame: 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao-jun Huang, M.D principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia and MDS, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Lv, M.D,Ph.D (+861088324637, drlvmeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold of dPCR to predict conventional MRD (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.