Status:
RECRUITING
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Fujian Children's Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Conditions:
B-Cell Lymphoblastic Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06607419
Start Date
May 21 2024
End Date
May 31 2030
Last Update
September 23 2024
Active Locations (4)
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1
Anhui Provincial Children's Hospital
Hefei, Anhui, China, 230051
2
Fujian Children's Hospital
Fuzhou, Fujian, China, 350011
3
Shanghai Children's Medical center
Shanghai, Shanghai Municipality, China, 200127
4
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, China, 315012