B Acute Lymphoblastic LeukemiaNCT04977895
Monitoring Minimal Residual Disease（MRD）in Pediatric B-acute Lymphoblastic Leukemia
An observational study of B Acute Lymphoblastic Leukemia, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aimed to investigate the performance of next-generation sequencing (NGS) techniques measuring immunoglobulin heavy chain (IgH)-variable, diversity, and joining (V[D]J) clonal rearrangements （IgH-V[D]J NGS） compared with flow cytometry (FCM) in detecting of minimal residual disease (MRD) for children with… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- B Acute Lymphoblastic Leukemia
- What is being tested?
- Minimal residual disease (MRD) monitoring
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2021to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under age of 18 years with newly diagnosed B-ALL
Who may be able to join
- Age≤18 years.
- Newly diagnosed B-ALL.
- No previous treatment.
- Signed informed consent in keeping with the policies of the hospital.
Who cannot join
- History of other malignancies, except in situ carcinoma or malignancy treated with curative intent.
- Patients with active or uncontrollable infections such as hepatitis B, hepatitis C or HIV infection.
- Patients with uncontrolled autoimmune diseases or immune defects. Other protocol-defined Inclusion/Exclusion may apply.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yi-Zhuo Zhang, MD, 18622221239, zhangyzh@sysucc.org.cn
Yi-Zhuo Zhang, MD
About this study
Official title: A Study to Assess Minimal Residual Disease by Next-generation Sequencing of Immunoglobulin Gene Rearrangements in Pediatric B-acute Lymphoblastic Leukemia
This study aimed to investigate the performance of next-generation sequencing (NGS) techniques measuring immunoglobulin heavy chain (IgH)-variable, diversity, and joining (V[D]J) clonal rearrangements （IgH-V[D]J NGS） compared with flow cytometry (FCM) in detecting of minimal residual disease (MRD) for children with acute lymphoblastic leukemia treated with South Chinese Children Leukemia Group (SCCLG)-ALL 2016, and to predict the relapse of the disease in the early stage and to assess the prognosis, so as to provide the basis for early intervention treatment and reduce the hematological relapse and improve the survival rate.
Read the detailed description
The measurement of residual leukemia levels, "minimal residual disease" (MRD), during therapy has now emerged as the most important predictor the outcome in acute lymphoblastic leukemia (ALL). As a result, risk-classifications based on MRD assessment has become an essential part of determining disease risk and directing therapeutic approach for children and adults with ALL.
Recently, next-generation sequencing (NGS) techniques measuring immunoglobulin (Ig) or T-cell receptor (TCR) clonal rearrangements as a method of detecting MRD have been introduced. These approaches expand the sensitivity of MRD detection to as high as 1 in 10,000,000 cells and have been shown to be predictive of relapse in children with ALL receiving standard chemotherapy.
In this study, the investigators will determine the sensitivity and specificity of IgH-V(D)J NGS and compared its capacity to measure MRD with that of flow cytometry using diagnostic and follow-up samples from more than 100 patients with ALL. Patients under age of 18 years with newly diagnosed ALL will be recruited and receive the treatment strategy of (SCCLG)-ALL 2016. After identifying a trackable clone in diagnostic samples (Baseline), MRD was measured using IgH-V(D)J NGS and FCM on bone marrow at 3 time-points: fifteen days after induction therapy (D15), thirty-three days after induction therapy (D33) and then at the end of induction therapy. Event-free survival (EFS), Relapse-free survival (RFS) and overall survival (OS) were assessed.
- Conditions
- B Acute Lymphoblastic Leukemia
- Being tested
- Minimal residual disease (MRD) monitoring
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal residual disease (MRD) monitoringDiagnostic test
Minimal residual disease (MRD) assay using IgH-V(D)J NGS and FCM
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of MRD detection by IgH V(D)J NGS and FCM
The percentage of participants with MRD positive status from baseline to induction treatment completion determined by by IgH V(D)J NGS and FCM
Measured: During Induction Phase: up to 3 months
Relapse-free survival (RFS)
RFS was estimated from the date of diagnosis until the date of relapse at any site. For other participants, last follow-up available was taken as last control. If participant did not complete study, date of last visit available was considered.
Measured: up to 5 years
Secondary outcomes (3)
MRD dynamic
MRD (IgH V(D)J NGS and/or FCM) dynamic between check-points
Measured: During Induction Phase: up to 3 months
Overall survival (OS)
OS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.
Measured: up to 5 years
Event-free survival (EFS)
EFS was estimated from date of diagnosis until date of one of the following events: relapse, refractory disease, second malignancy or death from any reason.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start30 Jan 2021
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
- Investigators
- Yi-Zhuo Zhang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977895
- Sponsor's protocol ID
- MRD
- Status last verified
- Jul 2021
- First submitted
- 11 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Minimal Residual Disease by Next-generation Sequencing of Immunoglobulin Gene Rearrangements in Pediatric B-acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04977895
- Acronym / sponsor ID
- MRD
- Conditions
- B Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 27 Jul 2021 (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.
This study aimed to investigate the performance of next-generation sequencing (NGS) techniques measuring immunoglobulin heavy chain (IgH)-variable, diversity, and joining (V[D]J) clonal rearrangements （IgH-V[D]J NGS） compared with flow cytometry (FCM) in detecting of minimal residual disease (MRD) for children with acute lymphoblastic leukemia treated with South Chinese Children Leukemia Group (SCCLG)-ALL 2016, and to predict the relapse of the disease in the early stage and to assess the prognosis, so as to provide the basis for early intervention treatment and reduce the hematological relapse and improve the survival rate.
Detailed description
The measurement of residual leukemia levels, "minimal residual disease" (MRD), during therapy has now emerged as the most important predictor the outcome in acute lymphoblastic leukemia (ALL). As a result, risk-classifications based on MRD assessment has become an essential part of determining disease risk and directing therapeutic approach for children and adults with ALL.
Recently, next-generation sequencing (NGS) techniques measuring immunoglobulin (Ig) or T-cell receptor (TCR) clonal rearrangements as a method of detecting MRD have been introduced. These approaches expand the sensitivity of MRD detection to as high as 1 in 10,000,000 cells and have been shown to be predictive of relapse in children with ALL receiving standard chemotherapy.
In this study, the investigators will determine the sensitivity and specificity of IgH-V(D)J NGS and compared its capacity to measure MRD with that of flow cytometry using diagnostic and follow-up samples from more than 100 patients with ALL. Patients under age of 18 years with newly diagnosed ALL will be recruited and receive the treatment strategy of (SCCLG)-ALL 2016. After identifying a trackable clone in diagnostic samples (Baseline), MRD was measured using IgH-V(D)J NGS and FCM on bone marrow at 3 time-points: fifteen days after induction therapy (D15), thirty-three days after induction therapy (D33) and then at the end of induction therapy. Event-free survival (EFS), Relapse-free survival (RFS) and overall survival (OS) were assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under age of 18 years with newly diagnosed B-ALL
Key inclusion criteria (4 listed)
- Age≤18 years.
- Newly diagnosed B-ALL.
- No previous treatment.
- Signed informed consent in keeping with the policies of the hospital.
Key exclusion criteria (3 listed)
- History of other malignancies, except in situ carcinoma or malignancy treated with curative intent.
- Patients with active or uncontrollable infections such as hepatitis B, hepatitis C or HIV infection.
- Patients with uncontrolled autoimmune diseases or immune defects. Other protocol-defined Inclusion/Exclusion may apply.
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 |
|---|---|---|
| Minimal residual disease (MRD) monitoringMinimal residual disease (MRD) assay using IgH-V(D)J NGS and FCM | Diagnostic test | – |
Primary outcome
The sensitivity of MRD detection by IgH V(D)J NGS and FCM
Time frame: During Induction Phase: up to 3 months
The percentage of participants with MRD positive status from baseline to induction treatment completion determined by by IgH V(D)J NGS and FCM
Relapse-free survival (RFS)
Time frame: up to 5 years
RFS was estimated from the date of diagnosis until the date of relapse at any site. For other participants, last follow-up available was taken as last control. If participant did not complete study, date of last visit available was considered.
3 secondary outcomes
MRD dynamic
Time frame: During Induction Phase: up to 3 months
Overall survival (OS)
Time frame: up to 5 years
Event-free survival (EFS)
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yi-Zhuo Zhang, MD principal investigator
Sun Yat-sen University
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 B Acute Lymphoblastic Leukemia, run by Sun Yat-sen University 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Zhuo Zhang, MD (18622221239, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of MRD detection by IgH V(D)J NGS and FCM (time frame: During Induction Phase: up to 3 months). The study lists 2 primary outcomes in all. 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 27 Jul 2021.