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China Children's Leukemia Group (CCLG)-ALL2018 supplementary study on pediatric precursor B-cell acute lymphoblastic leukemia-Blinatumomab therapy

China Children's Leukemia Group (CCLG)-ALL2018 supplementary study on pediatric precursor B-cell acute lymphoblastic leukemia-Blinatumomab therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083570
Enrollment
Unknown
Registered
2024-04-28
Start date
2024-04-28
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

pediatric precursor B-cell acute lymphoblastic leukemia

Interventions

MR group:On day 19 of induction therapy, blinatumomab was added for 14 days to replace subsequent induction therapy.
HR group:On day 19 of induction therapy, blinatumomab was added for 28 days to replace subsequent induction therapy.

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with CD19-positive BCP-ALL, younger than 18 years old 2. Enrolled in the CCLG-ALL2018 multi-center research protocol and stratified in the intermediate-risk group who have MRD = 1% on the 15th day of induction therapy, and patients in the high-risk group who have been identified after the 15th day of induction therapy. 3. Obtain written informed consent from the parents or legal guardians

Exclusion criteria

Exclusion criteria: 1. Mature B, T-ALL, CD19-negative B-ALL, acute mixed leukemia; 2. ALL secondary to immunodeficiency disease or inherited metabolic disorders; 3. ALL with Down's syndrom; 4. Patients who fail to receive systematic chemotherapy according to the protocol; 5. Patients with clear space-occupying brain parenchyma upon initial diagnosis and those with CNSL who were initially diagnosed and not relieved after treatment

Design outcomes

Primary

MeasureTime frame
minimal residual disease,;

Secondary

MeasureTime frame
remission state of bone marrow;one year event-free survival;overall survival;one year recurrence rate;death rate;

Countries

China

Contacts

Public ContactRuidong Zhang;Tianyou Wang

Beijing Children's Hospital, Capital Medical University

zhangruidong@bch.com.cn+86 10 5961 2223

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026