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A multicenter prospective cohort study of the acute lymphoblastic leukemia 2023 protocol of the South China Children’s Cancer Group

A multicenter prospective cohort study of the acute lymphoblastic leukemia 2023 protocol of the South China Children’s Cancer Group

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075242
Enrollment
Unknown
Registered
2023-08-30
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 acute lymphoblastic leukemia

Interventions

ALL:induction remission, consolidation,reinduction, maintainance

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 1 and 18 years; 2. Patients diagnosed with acute lymphoblastic leukemia (all); 3. First diagnosed patients; 4. 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.Those whose lives are in danger and have a life expectancy of less than 6 months. 14.Any significant other medical condition, laboratory abnormality, or psychiatric illness that the investigators consider unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Overall survival;Event free survival;Cumulative incidence rate;Grade 3 and 4 adverse side effect incidence;

Secondary

MeasureTime frame
Complete remission;Minimal residual disease;Any grade for adverse side effect incidence;Basic Activities of Daily Living Assessment Score;

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