Phase
Condition
Leukemia
Treatment
Blinatumomab
Clinical Study ID
Ages 1-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andaccept the informed consent approved by the Ethics Committee
Exclusion
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 dayswithin one month before enrollment, or any chemotherapy or radiotherapy within 3months before enrollment (except for emergency radiotherapy to relieve airwaycompression);
Initial diagnosis of high risk;
D46MRD ≥1%.
Study Design
Connect with a study center
Anhui Provincial Children's Hospital
Hefei, Anhui 230051
ChinaSite Not Available
Fujian Children's Hospital
Fuzhou, Fujian 350011
ChinaSite Not Available
Shanghai Children's Medical center
Shanghai, Shanghai 200127
ChinaActive - Recruiting
Ningbo Women and Children's Hospital
Ningbo, Zhejiang 315012
ChinaActive - Recruiting
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