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AzTrials

Lymphoblastic Leukemia in ChildrenPhase 2SR ALLNCT06099366

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

A Phase 2 study testing induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate, Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate and Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate in people with Lymphoblastic Leukemia in Children, run by Hee Young Ju at 13 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 9 years
Conditions the study is for
Lymphoblastic Leukemia in Children
What is being tested?
induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate, Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate and Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
13 sitesSouth Korea
Study dates
5 Mar 2024to 31 Dec 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 9 years
  • All sexes
  • No healthy volunteers
  • Child

<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
  5. 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.

  1. 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

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hee Young Ju, MD, Phd contact

82-2-3410-0865

heeyoung.ju@samsung.com

hyunjung Shin contact

82-2-3410-6763

hjds.shin@samsung.com

13 sites in 1 country

South Korea13 sites, 13 recruiting

  • Kyungpook National University Chilgok-Hospital

    Daegu, 41404

    Ji Yoon Kim, Professor, +82-53-200-5704, phojyk@knu.ac.kr

    Not yet recruiting

  • Chungnam National University Hospital

    Daejeon, 35015

    Yeon Jung Lim, Professor, 82-10-2705-1743, heagori@daum.net

    Not yet recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

    Hee Jo Baek, Professor, +82-61-379-8060, swan93@naver.com

    Not yet recruiting

  • Jeju National University Hospital

    Jeju City, 63241

    Hyun Sik Kang, Professor, +82-64-717-1528, medyapsb@naver.com

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    Hyoung Soo Choi, Professor, +82-31-787-7797, choihs1786@gmail.com

    Recruiting

  • Asan Medical Center

    Seoul, Other (Non U.s.), 03174

    Hyery KIM, MD, PhD, 82-2-3010-3373, taban@hanmail.net

    Recruiting

  • Samsung Medical Center

    Seoul, Other (Non U.s.), 03174

    Hee Young Ju, MD, PhD, 82-2-3410-0865, heeyoung.ju@samsung.com

    hyunjung Shin, 82-2-3410-6763, hjds.shin@samsung.com

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Jun Eun Park, Professor, +82-10-9476-0932, pedonco@korea.ac.kr

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Hyoung Jin Kang, Professor, +82-2-2072-3452, kanghj@snu.ac.kr

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Seung-min Hahn, Professor, +82-2-2258-9943, bluenile88@yuhs.ac

    Recruiting

  • Seoul saint Mary's Hospital

    Seoul, 06591

    Jae Won Yoo, Professor, +82-2-2258-6763, hoiring0209@gmail.com

    Recruiting

  • Ajou University Medical Center

    Suwon, 16499

    Juyeon Lee, Professor, +82-31-219-5163, juyeon1437@naver.com

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Yangsan-si, 50612

    Eu Jeen Yang, Professor, +82-10-6478-8489, 41sirius@hanmail.net

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Being tested
induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate, Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate, Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate, Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate, Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Keywords
Standard Risk ALL, NGS MRD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal MethotrexateDrug

    vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate

  • Consolidation: Vincristine, Mecaptopurine, Intrathecal MethotrexateDrug

    Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate

  • Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal MethotrexateDrug

    Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate

  • Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal MethotrexateDrug

    Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate

  • Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal MethotrexateDrug

    Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate

  • Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal MethotrexateDrug

    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

  • Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal MethotrexateDrug

    Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

  • Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal MethotrexateDrug

    Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Study groups in NCT06099366
Study groupRoleWhat they receive
Standard-low (SL)ExperimentalInduction-> SL Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Receives: 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
Standard-average (SA)ExperimentalInduction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion-> Interim Maintenance 2nd-> Maintenance
Receives: Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, 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
Standard-high 1 (SH1)ExperimentalInduction-> SL Consolidation(4weeks)-> Intesified Consolidattion(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Receives: Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, 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; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Standard-high 2 (SH2)ExperimentalInduction-> SH Consolidation(4weeks)-> Intensified Consolidation(4weeks)-> Interim Maintenance 1st-> Delayed Intesificaion 1st-> Interim Maintenance 2nd-> Delayed Intestificaion 2nd-> Maintenance
Receives: Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, 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; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-year event free survival rate

    Measured: Up to 5-years

Secondary outcomes (2)

  1. Confirmation of the therapeutic effect of the initial treatment response

    Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment

    Measured: Up to 5-years

  2. Disease prognosis-related factor

    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.

    Measured: Up to 5-years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2023
  2. Study start5 Mar 2024
  3. Primary completion31 Dec 2033 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099366
Sponsor's protocol ID
2023-09-142
Acronym
SR ALL
Status last verified
Jul 2026
First submitted
18 Oct 2023
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate, Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate and Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate in people with Lymphoblastic Leukemia in Children, run by Hee Young Ju at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hee Young Ju, MD, Phd (82-2-3410-0865, heeyoung.ju@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-year event free survival rate (time frame: Up to 5-years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06099366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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