Clinical trial NCT06099366: Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
Official title: Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lymphoblastic Leukemia in Children
Keywords: Standard Risk ALL
NGS MRD
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Seoul National University Hospital
name: Seoul St. Mary's Hospital
name: Severance Hospital
name: Pusan National University Yangsan Hospital
name: Korea University Anam Hospital
name: Chonnam National University Hospital
name: Jeju National University Hospital
First posted: 2023-10-25
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: \<Inclusion Criteria\>

* Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following

  1. 1 year old ≤ Age \< 10 years old
  2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL)
  3. No testis involvement
  4. 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

\<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. Newly diagnosed T cell ALL
4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
5. Burkitt leukemia/lymphoma
6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Primary outcomes:
measure: 5-year event free survival rate
timeFrame: Up to 5-years
Secondary outcomes:
measure: Confirmation of the therapeutic effect of the initial treatment response
timeFrame: Up to 5-years
measure: Disease prognosis-related factor
timeFrame: Up to 5-years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Other (Non U.S.)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Other (Non U.S.)
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Yangsan-si
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul saint Mary's Hospital
Study officials:
References: