Childhood acute lymphoblastic leukemia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Overall survival;Event free survival;Cumulative incidence rate;Grade 3 and 4 adverse side effect incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission;Minimal residual disease;Any grade for adverse side effect incidence;Basic Activities of Daily Living Assessment Score; | — |
Countries
China
Contacts
Sun Yat-Sen Memorial Hosipital of Sun Yat-Sen University