Pediatric Acute Lymphoblastic LeukemiaPhase 2HR ALLNCT06184009
Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia
A Phase 2 study testing ALL, High risk in people with Pediatric Acute Lymphoblastic Leukemia, run by Jae Wook Lee at 9 sites in South Korea.
Trial summary
Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Pediatric Acute Lymphoblastic Leukemia
- What is being tested?
- ALL, High risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 10 Aug 2024to 31 Dec 2030
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
<Inclusion Criteria>
- Age: 1year~19years of age at diagnosis
- Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
- High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10^9/L at diagnosis
- If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
- High-risk gene variants:
KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21)
● If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification.
- Newly diagnosed T cell ALL
<Exclusion Criteria>
- Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
- Patients with Down syndrome
- potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
- Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
- Participating in an interventional clinical trial other than this research
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
South Korea9 sites, 9 recruiting
- Not yet recruiting
Inha University Hospital
Incheon, 22332
Jeong A Park, Professor, +82-32-890-3843, jeonga95@gmail.com
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
Hyungjin Kang, MD, PhD, 82-010-3685-5164, kanghj@snu.ac.kr
- Recruiting
Samsung Medical Center
Seoul, Seoul
Heeyoung Ju, MD, PhD, 82-02-3410-6957, hyju320@gmail.com
- Not yet recruiting
Korea University Anam Hospital
Seoul, 02841
Jun Eun Park, Professor, +82-10-9476-0932, pedonco@korea.ac.kr
- Recruiting
Severance Hospital
Seoul, 03722
Seung min Hahn, MD, 82-02-2228-2050, bluenile88@yuhs.ac
- Recruiting
Asan Medical Center
Seoul, 05505
Hyery Kim, Ph.D, 82-2-3010-3373, taban@hanmail.net
- Recruiting
Seoul saint Mary's Hospital
Seoul, 06591
Jae Wook Lee, Professor, 82-010-3249-0496, dashwood@catholic.ac.kr
- Recruiting
Ajou University Hospital
Suwon, 16499
Juyeon Lee, Professor, +82-31-219-5163, juyeon1437@naver.com
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Eu Jeen Yang, Professor, +82-10-6478-8489, 41sirius@hanmail.net
About this study
Official title: Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study
- Clinical and genetic factors consistent with High risk : Induction → Consolidation
- BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance
- BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after Consolidation <!-- -->
- T cell ALL : Change to very high risk regimen
- Pre-B ALL : IM #1 → Intensification
- BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
- Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.
Read the detailed description
- Clinical and genetic factors consistent with High risk : Induction → Consolidation
- BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
- BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after Consolidation <!-- -->
- T cell ALL : Change to very high risk regimen
- Pre-B ALL : IM #1 → Intensification
- BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
- T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.
- Conditions
- Pediatric Acute Lymphoblastic Leukemia
- Being tested
- ALL, High risk
- Keywords
- HR ALL, NGS-MRD
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALL, High riskDrug
Intervention Description :
- Clinical and genetic factors consistent with High risk : Induction → Consolidation
- BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
- BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after Consolidation <!-- -->
- T cell ALL : Change to very high risk regimen
- Pre-B ALL : IM #1 → Intensification
- BM MRD \< 0.01% after IM #1 : Continue with \'No. 2\' of High risk regimen starting with DI #1
- BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
- T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.
| Study group | Role | What they receive |
|---|---|---|
| ALL, High risk with DI #2(Doxorubicin) | Experimental | * Clinical and genetic factors consistent with High risk : Induction → Consolidation
1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
2. BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
3. BM MRD ≥ 0.01% after Consolidation
<!-- -->
1. T cell ALL : Change to very high risk regimen
2. Pre-B ALL : IM #1 → Intensification
1. BM MRD \< 0.01% after IM #1 : Continue with \'No. 2\' of High risk regimen starting with DI #1
2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
* T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported. Receives: Drug: ALL, High risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Event-free survival rate for 5 years from the date of registration
Measured: Up to 5 years
Secondary outcomes (3)
Overall Survival
The time until defined by date of all-cause mortality from the date of 1st infusion
Measured: Up to 5 years
Recurred rate
As the period from enrollment to disease progression/recurrence
Measured: Up to 5 years
Death rate related to infusion
The time until defined by date of drug-related mortality from the date of 1st infusion
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.
- First posted28 Dec 2023
- Study start10 Aug 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jae Wook Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital, Pusan National University Yangsan Hospital, Korea University Anam Hospital, Ajou University School of Medicine, Inha University Hospital
- Responsible party
- Sponsor-investigator, Jae Wook Lee, Seoul St. Mary's Hospital
- Investigators
- Jae Wook Lee, Ph.D, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184009
- Sponsor's protocol ID
- 2023-3626-0001
- Acronym
- HR ALL
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia-prospective, Nationwide, Multi-center Study
- ClinicalTrials.gov ID
- NCT06184009
- Acronym / sponsor ID
- HR ALL / 2023-3626-0001
- Conditions
- Pediatric Acute Lymphoblastic Leukemia
- Keywords
- HR ALL, NGS-MRD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Jae Wook LeeUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital, Pusan National University Yangsan Hospital, Korea University Anam Hospital, Ajou University School of Medicine, Inha University Hospital
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Clinical and genetic factors consistent with High risk : Induction → Consolidation
- BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance
- BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after Consolidation <!-- -->
- T cell ALL : Change to very high risk regimen
- Pre-B ALL : IM #1 → Intensification
- BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
- Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.
Detailed description
- Clinical and genetic factors consistent with High risk : Induction → Consolidation
- BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance
- BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after Consolidation <!-- -->
- T cell ALL : Change to very high risk regimen
- Pre-B ALL : IM #1 → Intensification
- BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance
- BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
- T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL, High risk with DI #2(Doxorubicin) | Experimental | Drug: ALL, High risk* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \< 0.01% after IM #1 : Continue with \'No. 2\' of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported. |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALL, High riskIntervention Description : * Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \< 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \< 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \< 0.01% after IM #1 : Continue with \'No. 2\' of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported. | Drug | ALL, High risk with DI #2(Doxorubicin) |
Primary outcome
Event Free Survival
Time frame: Up to 5 years
Event-free survival rate for 5 years from the date of registration
3 secondary outcomes
Overall Survival
Time frame: Up to 5 years
Recurred rate
Time frame: Up to 5 years
Death rate related to infusion
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jae Wook Lee, Ph.D study chair
The Catholic University of Korea
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALL, High risk in people with Pediatric Acute Lymphoblastic Leukemia, run by Jae Wook Lee at 9 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 9 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 Jae Wook Lee, Ph.D (82-2-2258-6192, dashwood@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (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?
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.