A study to evaluate the clinical efficacy of chemotherapy combined with bispecific antibodies in the treatment of pediatric B-cell acute leukemia with high risk of relapse

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083604

Enrollment

Unknown

Registered

2024-04-29

Start date

2024-04-29

Completion date

Unknown

Last updated

2024-05-06

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

experimental group:Chemotherapy Combined with Blinatumomab

control group:Chemotherapy

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. Children in the intermediate-risk group with MRD =1% on day 15 of induction therapy and/or with high-risk adverse genetic features; 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

Measure	Time frame
minimal residual disease;	—

Secondary

Measure	Time frame
one year event-free survival;overall survival;death rate;	—

Countries

China

Contacts

Public ContactRuidong Zhang

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 4, 2026