Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

• Status: Recruiting
• Trial end date: 2033-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for standard risk acute lymphoblastic leukemia in children and adolescents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hee Young Ju
• Treatments: Asparaginase; BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Vincristine

Criteria

Inclusion Criteria:

• Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following

1. 1 year old ≤ Age < 10 years old

2. white blood cell at initial diagnosis < 5x10^10/L (50,000uL)

3. CNS 1 or 2

4. No testis involvement

5. Satisfaction of following organ functions

A. Kidney function (satisfies i or ii)

i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2

ii. Creatinine value according to age/sec satisfies the following: 1 to < 2 years: Male: 0.6 / Female: 0.6, 2 to < 6 years: Male: 0.8 / Female: 0.8, 6 to < 10 years: Male: 1 / Female: 1, 10 to < 13 years: Male: 1.2 / Female: 1.2, 13 to < 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.

B. Liver function i. Direct bilirubin < 3.0mg/dL

C. Cardiac function i. Shortening fraction ≥ 27% confirmed by cardiac echography ii. Ejection fraction ≥ 50% confirmed by cardiac echography

Exclusion Criteria:

• Steroid administration within 2 weeks before the registration

• t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF

• One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome

• Burkitt leukemia/lymphoma

• When the clinical trial subject(or legal representative) does not consent or is unable to give written consent