Blinatumomab: Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Study summary
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:
• If the flow cytometric MRD negative (\<0.01%) rate and the NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol).
Participants will:
* Take 14 days full dose Blinatumomab;
* With bone marrow evaluated before and after Blinatumomab treatment.
Eligibility
Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* Age older than 1 month to younger than 18 years.
* Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
* Immunophenotyping: acute B-lymphoblastic leukemia;
* Meet one of the following situations:
A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
* Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
Exclusion Criteria:
* sIgM+;
* ALL evolved from chronic myeloid leukemia (CML);
* Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
* Other secondary leukemias;
* CNS involvement;
* History of epilepsy; or convulsions within the last month;
* Known underlying congenital immunodeficiency or metabolic disease;
* Congenital heart disease with cardiac insufficiency;
* Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
* Initial diagnosis of high risk;
* D46MRD ≥1%.
Primary outcome measure(s)
The flow cytometric MRD — From the date of Blinatumomab completion to one week after its treatment course The flow cytometric MRD negative (\<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
The NGS- MRD — From the date of Blinatumomab completion to one week after its treatment course The NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol)
Trial sites (4)
Facility
City
Region
Status
Anhui Provincial Children's Hospital
Hefei
Anhui
Not Yet Recruiting
Fujian Children's Hospital
Fuzhou
Fujian
Not Yet Recruiting
Shanghai Children's Medical center
Shanghai
Shanghai Municipality
Recruiting
Ningbo Women and Children's Hospital
Ningbo
Zhejiang
Recruiting
More Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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