Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children.

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0009042
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

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

1 year old = Age < 10 years old
2. white blood cell at initial diagnosis < 50 X 10³/µL (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

1. Steroid administration within 2 weeks before the registration
2. t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF
3. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
4. Burkitt leukemia/lymphoma or mature B-cell leukemia
5. When the clinical trial subject(or legal representative) does not consent or is unable to give written consen

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified