Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Phase 2

Recruiting

• Conditions: Lymphoblastic Leukemia in Children

• Registration Number: NCT06099366
• Lead Sponsor: Hee Young Ju

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-25
• Study Start: 2024-03-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

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. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5-year event free survival rate	Up to 5-years

Secondary Outcome Measures

Name	Time	Method
Disease prognosis-related factor	Up to 5-years	Relapse-free survival according to presence or absence of known good prognosis factors(high hyperdilpoidy, ETV6/RUNX1, Trisomy 4/10/17) have no clinical significance when NGS MRD based stratified treatment is performed.
Confirmation of the therapeutic effect of the initial treatment response	Up to 5-years	Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment

Trial Locations

Locations (2)

Samsung Medical Center; 🇰🇷 Seoul, Other (Non U.s.), Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Other (Non U.s.), Korea, Republic of