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A prospective multicenter, open and controlled study for the 2016 program of the South China children's acute lymphoblastic leukemia treatment cooperation group

A prospective multicenter, open and controlled study for the 2016 program of the South China children's acute lymphoblastic leukemia treatment cooperation group

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030357
Enrollment
Unknown
Registered
2020-02-29
Start date
2020-03-01
Completion date
Unknown
Last updated
2022-04-19

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

LR control group:mM consolidation
LR experimental group:EMV consolidation
IR:PEG-ASP
BCR/ABL HR control group:6 courses of block consolidation
BCR/ABL HR experimental group:3 courses of consolidation

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 <= 18 years; 2. Patients diagnosed with acute lymphoblastic leukemia (all); 3. New onset patients; 4. Who will sign the informed consent for chemotherapy; 5. Who will participate randomized control researchers to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with mature B-cell leukemia; 2. With acute mixed-phenotypic leukemia (see annex I for diagnostic criteria); 3. With secondary immunodeficiency; 4. Patients with leukemia which is the second tumor; 5. With definite CML abrupt change; 6. ALL with Down's syndrome; 7. Patients who used glucocorticoids for more than one week in the month before enrollment; 8. Patients who used anthracyclines within one month before enrollment.

Design outcomes

Primary

MeasureTime frame
remission;40-day remission with incomplete recovery of blood;overall survival;5-year event free survival;5-year accumulated recurrency;

Secondary

MeasureTime frame
accumulated infection incidence;accumulated side effect incidence;accumulated leukemia related mortality;

Countries

China

Contacts

Public ContactJianpei Fang

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

jpfang2005@163.com+86 13682290830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026