B Cell Precursor Acute Lymphoblastic LeukemiaNCT06763302
NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL
A study testing Blinatumomab in people with B Cell Precursor Acute Lymphoblastic Leukemia and Pediatric, run by The Children's Hospital of Zhejiang University School of Medicine.
Trial summary
The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- B Cell Precursor Acute Lymphoblastic Leukemia, Pediatric, Minimal Residual Disease
- What is being tested?
- Blinatumomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Interventional
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
Who may be able to join
- Clincial dianogsis of acute lymphoblastic leukemia (B-cell type) by morphology, immunology, cytogenetics, and molecular biology (MICM).
- Age ≥1 year and <18 years.
- Informed consent signed, with the parents or guardians agreeing to a unified treatment protocol.
Who cannot join
- Age <1 year or ≥18 years.
- Immunophenotyping suggests mature B-cell leukemia, mixed-lineage leukemia, or T-cell acute lymphoblastic leukemia.
- Secondary leukemia or second tumor, CML blast phase ALL.
- Other tumors or immunodeficiency diseases present.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to determine whether pediatric B-cell acute lymphoblastic leukemia (B-ALL) patients with negative deep minimal residue disease (MRD) can benefit from blinatumomab treatment.
The main questions it aims to answer are:
- Whether the application of blinatumomab can improve the long-term survival of next generation sequence (NGS) MRD-positive B-ALL children after consolidation therapy?
- Whether the application of blinatumomab can benefit the NGS MRD-negative B-ALL children after consolidation therapy?
- Conditions
- B Cell Precursor Acute Lymphoblastic Leukemia, Pediatric, Minimal Residual Disease, Next Generation Sequencing (NGS)
- Being tested
- Blinatumomab
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
The FDA has approved blinatumomab for post-consolidation treatment in all Ph-negative B-ALL cases, regardless of MRD status. Considering the high cost of blinatumomab and the financial burden on families, we aim to precisely identify the population who would benefit from blinatumomab and provide appropriate treatment.
| Study group | Role | What they receive |
|---|---|---|
| EOC NGS MRD positive Group | Experimental | Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is positive (≥0.0001%), one course of blinatumomab (28 days) will be added after the consolidation treatment. Receives: Drug: Blinatumomab |
| EOC NGS MRD negative Group A | Active comparator | Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group A will be added by one course of blinatumomab (28 days) treatment after the consolidation treatment. Receives: Drug: Blinatumomab |
| EOC NGS MRD negative Group B | No intervention | Based on the B-ALL treatment protocol, NGS MRD levels will be monitored at the end of consolidation treatment (EOC). If NGS MRD is negative (< 0.0001%), the IR/HR patients will be randomized into A and B two groups. EOC NGS MRD negative Group B will continue the original chemotherapy treatment plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
Death during induction, abandonment before complete remission, death in continuous complete remission, relapse, and secondary Death during induction, abandonment before complete remission (CR), death in continuous complete remission (CCR), relapse, and secondary malignancies were considered as events in the calculation of EFS probability.
Measured: From enrollment to the 3-year after the end of treatment
Relapse free survival
RFS was measured by the time from achievement of CR to last follow-up or first relapse and censored at the first event (death, secondary malignancies) except relapse.
Measured: From enrollment to the 3-year after the end of treatment
Secondary outcomes (1)
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: From enrollment to the 3-year after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B Cell Precursor Acute Lymphoblastic LeukemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojun Xu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763302
- Sponsor's protocol ID
- 2024-IRB-0307-P-01
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen H, Gu M, Liang J, Song H, Zhang J, Xu W, Zhao F, Shen D, Shen H, Liao C, Tang Y, Xu X. Minimal residual disease detection by next-generation sequencing of different immunoglobulin gene rearrangements in pediatric B-ALL. Nat Commun. 2023 Nov 17;14(1):7468. doi: 10.1038/s41467-023-43171-9.
PubMed 37978187