A real-world study of the use of blinatumomab bridging maintenance therapy after chemotherapy for B-cell acute lymphoblastic leukemia in children with intermediate risk

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300075198

Enrollment

Unknown

Registered

2023-08-29

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-09-04

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

Conditions

Childhood B-cell acute lymphoblastic leukemia

Interventions

Intermediate-risk B-ALL blinatumomab control group:VDLD,CAM,L

Intermediate-risk B-ALL blinatumomab experimental group:VDLD,CAM,L,Blinatumomab

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.The age at the time of signing informed consent = 1 and under the age of 18; 2. Patients diagnosed with B-cell acute lymphoblastic leukemia (b-ALL); 3. New onset patients; 4. Who is classified as a medium-risk group according to the SCCCG-ALL-2023 program evaluation indicators; 5. Who has been achieved complete remission after early treatment and has conditions for entering maintenance therapy; 6. Who will participate research and guardian to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.With acute mixed-phenotypic leukemia (see annex I of the researcher's manual for diagnostic criteria); 2. With secondary immunodeficiency; 3. Patients with leukemia which is the second tumor; 4. With definite CML abrupt change; 5.ALL with Down's syndrome; 6. Patients who used glucocorticoids for more than one week in the month before enrollment; 7. Patients who used anthracyclines within one month before enrollment. 8.Severe hepatic insufficiency(ALT or AST =3xULN). 9.Severe renal impairment (eGFR < 30 ml/min/1.73m3 or end-stage renal disease patients). 10.Heart disease, New York Heart Association (NYHA) classification of grade 3 or above heart failure, or severe arrhythmia requiring treatment, or recent myocardial infarction within 6 months after randomization. 11.Patients with a history of deep vein thrombosis or stroke within 24 weeks prior to enrollment. 12.Patients with a history of acute or chronic pancreatitis within 24 weeks prior to enrollment. 13.Any significant other medical condition, laboratory abnormality, or psychiatric illness that the investigators consider unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Relapse free survival;	—

Secondary

Measure	Time frame
Overall survival;Event-free survival;Cumulative incidence of relapse;	—

Countries

China

Contacts

Public ContactJianpei Fang

Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University

jpfang2005@163.com+86 136 8229 0830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026