Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
About this study
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.
- Condition
- B-Cell Lymphoblastic Leukemia
- Tested
- Blinatumomab
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Who can join
- Age
- 0.08 to 18 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 9
- Minimum age: 0.08 years
- Maximum age: 18 years
- Study condition: B-Cell Lymphoblastic Leukemia
- 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 11
- 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%.
Where
4 sites, 4 recruiting
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, China
Shanghai Children's Medical center
Shanghai, Shanghai Municipality, China
Fujian Children's Hospital
Fuzhou, Fujian, China
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Contact
-
Shuhong Shen, PhD/MD
86-18930830638 shenshuhong@scmc.com.cn
-
Wenting Hu, MD
13524836748 huwenting@scmc.com.cn
Potential match only. Final eligibility is determined by the study team.