Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
- Registration Number
- NCT06607419
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Blinatumomab Blinatumomab Patients in this group should receive Blinatumomab
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 5-year EFS 5 years since the last recruited patient completed Blinatumomab. The 5-year EFS of study group was significantly higher than that of the control group.
Adverse events From day 19 of induction therapy until the start of the second high-dose methotrexate regimen. Comparison of adverse events in study and control groups
Healthcare costs Six-month since window phase Comparison of healthcare costs in study and control groups
Trial Locations
- Locations (4)
Anhui Provincial Children's Hospital
🇨🇳Hefei, Anhui, China
Fujian Children's Hospital
🇨🇳Fuzhou, Fujian, China
Shanghai Children's Medical center
🇨🇳Shanghai, Shanghai, China
Ningbo Women and Children's Hospital
🇨🇳Ningbo, Zhejiang, China