Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children (SR ALL)
July 28, 2026 updated by: Hee Young Ju
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
- Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
- Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
- Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
- Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
- Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
- Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
- Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
- Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Study Type
Interventional
Enrollment (Estimated)
116
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: hyunjung Shin
- Phone Number: 82-2-3410-6763
- Email: hjds.shin@samsung.com
Study Contact Backup
- Name: Hee Young Ju, MD, PhD
- Phone Number: 82-2-3410-0865
- Email: heeyoung.ju@samsung.com
Study Locations
-
-
-
Daegu, South Korea, 41404
- Not yet recruiting
- Kyungpook National University Chilgok-Hospital
-
Contact:
- Ji Yoon Kim, Professor
- Phone Number: +82-53-200-5704
- Email: phojyk@knu.ac.kr
-
Daejeon, South Korea, 35015
- Not yet recruiting
- Chungnam National University Hospital
-
Contact:
- Yeon Jung Lim, Professor
- Phone Number: 82-10-2705-1743
- Email: heagori@daum.net
-
Hwasun, South Korea, 58128
- Not yet recruiting
- Chonnam National University Hwasun Hospital
-
Contact:
- Hee Jo Baek, Professor
- Phone Number: +82-61-379-8060
- Email: swan93@naver.com
-
Jeju City, South Korea, 63241
- Recruiting
- Jeju National University Hospital
-
Contact:
- Hyun Sik Kang, Professor
- Phone Number: +82-64-717-1528
- Email: medyapsb@naver.com
-
Seongnam, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Hyoung Soo Choi, Professor
- Phone Number: +82-31-787-7797
- Email: choihs1786@gmail.com
-
Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Hyoung Jin Kang, Professor
- Phone Number: +82-2-2072-3452
- Email: kanghj@snu.ac.kr
-
Seoul, South Korea, 02841
- Recruiting
- Korea University Anam Hospital
-
Contact:
- Jun Eun Park, Professor
- Phone Number: +82-10-9476-0932
- Email: pedonco@korea.ac.kr
-
Seoul, South Korea, 03722
- Recruiting
- Severance Hospital
-
Contact:
- Seung-min Hahn, Professor
- Phone Number: +82-2-2258-9943
- Email: bluenile88@yuhs.ac
-
Seoul, South Korea, 06591
- Recruiting
- Seoul Saint Mary's Hospital
-
Contact:
- Jae Won Yoo, Professor
- Phone Number: +82-2-2258-6763
- Email: hoiring0209@gmail.com
-
Suwon, South Korea, 16499
- Recruiting
- Ajou University Medical Center
-
Contact:
- Juyeon Lee, Professor
- Phone Number: +82-31-219-5163
- Email: juyeon1437@naver.com
-
-
Other (Non U.s.)
-
Seoul, Other (Non U.s.), South Korea, 03174
- Recruiting
- Asan Medical Center
-
Contact:
- Hyery KIM, MD, PhD
- Phone Number: 82-2-3010-3373
- Email: taban@hanmail.net
-
Seoul, Other (Non U.s.), South Korea, 03174
- Recruiting
- Samsung Medical Center
-
Contact:
- hyunjung Shin
- Phone Number: 82-2-3410-6763
- Email: hjds.shin@samsung.com
-
Contact:
- Hee Young Ju, MD, PhD
- Phone Number: 82-2-3410-0865
- Email: heeyoung.ju@samsung.com
-
-
Yangsan-si
-
Yangsan, Yangsan-si, South Korea, 50612
- Recruiting
- Pusan National University Yangsan Hospital
-
Contact:
- Eu Jeen Yang, Professor
- Phone Number: +82-10-6478-8489
- Email: 41sirius@hanmail.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
<Inclusion Criteria>
Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following
- 1 year old ≤ Age < 10 years old
- white blood cell at initial diagnosis < 5x10^10/L (50,000uL)
- No testis involvement
- 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>
- 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
- Newly diagnosed T cell ALL
- 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
- In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
- When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard-low (SL)
Induction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
|
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
|
|
Experimental: Standard-average (SA)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
|
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
|
|
Experimental: Standard-high 1 (SH1)
Induction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
|
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
|
|
Experimental: Standard-high 2 (SH2)
Induction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
|
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
5-year event free survival rate
Time Frame: Up to 5-years
|
Up to 5-years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confirmation of the therapeutic effect of the initial treatment response
Time Frame: 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
|
Up to 5-years
|
|
Disease prognosis-related factor
Time Frame: 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.
|
Up to 5-years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2024
Primary Completion (Estimated)
December 31, 2033
Study Completion (Estimated)
December 31, 2033
Study Registration Dates
First Submitted
October 18, 2023
First Submitted That Met QC Criteria
October 24, 2023
First Posted (Actual)
October 25, 2023
Study Record Updates
Last Update Posted (Actual)
July 29, 2026
Last Update Submitted That Met QC Criteria
July 28, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Nucleic Acids, Nucleotides, and Nucleosides
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Glycosides
- Hydrolases
- Enzymes
- Enzymes and Coenzymes
- Purines
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Phosphoramide Mustards
- Nitrogen Mustard Compounds
- Mustard Compounds
- Hydrocarbons, Halogenated
- Phosphoramides
- Organophosphorus Compounds
- Nucleosides
- Pterins
- Pteridines
- Pregnadienetriols
- Amidohydrolases
- Arabinonucleosides
- Aminopterin
- Anthracyclines
- Naphthacenes
- Aminoglycosides
- Daunorubicin
- Sulfhydryl Compounds
- Dexamethasone
- Methotrexate
- Cyclophosphamide
- Cytarabine
- Doxorubicin
- Asparaginase
- Mercaptopurine
Other Study ID Numbers
- 2023-09-142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.