Acute Lymphoblastic Leukemia, PediatricNCT05837689
Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
An observational study of Acute Lymphoblastic Leukemia, Pediatric, run by Xiaojun Xu.
Trial summary
A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2023
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric BCP-ALL patients who were treated in our institution since Oct 2021
Who may be able to join
- Patients diagnosed with B cell precursor acute lymphoblastic leukemia
- Patients who received blinatumomab for consolidation
- Patients who were detected MRD positive by NGS before initiation of blinatumomab treatment
Who cannot join
- Patients without data of NGS detection after receiving blinatumomab treatment
About this study
A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the potential of using NGS to guide MRD eradication by blinatumomab.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- Blinatumomab
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
IV
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD clearance rate (MRD<0.00001%)
The change of MRD will be detected by NGS, with sensitivity of 0.00001% and 0.01%, respectively
Measured: before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaojun Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaojun Xu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837689
- Sponsor's protocol ID
- 2023-IRB-0062-P-01
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
- ClinicalTrials.gov ID
- NCT05837689
- Acronym / sponsor ID
- 2023-IRB-0062-P-01
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiaojun XuUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 1 May 2023 (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 retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the potential of using NGS to guide MRD eradication by blinatumomab.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric BCP-ALL patients who were treated in our institution since Oct 2021
Key inclusion criteria (3 listed)
- Patients diagnosed with B cell precursor acute lymphoblastic leukemia
- Patients who received blinatumomab for consolidation
- Patients who were detected MRD positive by NGS before initiation of blinatumomab treatment
Key exclusion criteria (1 listed)
- Patients without data of NGS detection after receiving blinatumomab treatment
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 |
|---|---|---|
| BlinatumomabIV | Drug | – |
Primary outcome
MRD clearance rate (MRD<0.00001%)
Time frame: before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment
The change of MRD will be detected by NGS, with sensitivity of 0.00001% and 0.01%, respectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, Pediatric, run by Xiaojun Xu.
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 1 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD clearance rate (MRD<0.00001%) (time frame: before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment). 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 1 May 2023.