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The research to investigate the efficacy, safety of blinatumomab (14 day) combined with chemotherapy in pediatrics subjects with day46 MRD-positive newly diagnosed B-ALL in intermediate/high-risk groups

The research to investigate the efficacy, safety of blinatumomab (14 day) combined with chemotherapy in pediatrics subjects with day46 MRD-positive newly diagnosed B-ALL in intermediate/high-risk groups

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053318
Enrollment
Unknown
Registered
2021-11-18
Start date
2022-05-18
Completion date
Unknown
Last updated
2023-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia (ALL)

Interventions

Blinatumomab group:Infusion of Blinatumomab for 14 days
control:No

Sponsors

Division of Pediatric Blood Diseases Center State Key Laboratory of Experimental Hematology, Institute of Hematology, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 month to 18 years; 2. CD 19+ B-acute lymphoblastic leukemia; 3. According to CCCG-ALL2020 plan, they were divided into medium-risk group and high-risk group; 4. MRD >= 0.01% on day 46 of induction chemotherapy; 5. Comply with relevant guidelines of institutional Review Board, NCI and FDA, and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who currently have active liver or biliary disease (e.g., gilbert syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease, as assessed by the treating physician); 2. Have a clinically relevant history of the central nervous system (CNS) or a disease such as epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis; patients with leukemia involving the central nervous system can be included; 3. Autoimmune disease or history of autoimmune disease that may involve the central nervous system; 4. Human immunodeficiency virus (HIV) positivity; 5. The diseases/infections that are active and uncontrolled as judged by the physician; 6. The guardian does not agree or cannot obtain the consent of the guardian.

Design outcomes

Primary

MeasureTime frame
MRD(Molecular Residual Disease);

Countries

China

Contacts

Public ContactZhu Xiaofan

Division of Pediatric Blood Diseases Center State Key Laboratory of Experimental Hematology, Institute of Hematology, Chinese Academy of Medical Sciences

xfzhu@ihcams.ac.cn+86 13752090418

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026