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Leukemia, LymphoidPhase 2NCT06516679

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

A Phase 2 study testing Consolidation #4(without daunorubicin), Consolidation #4(with daunorubicin) and Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin) in people with Leukemia, Lymphoid, run by Yonsei University at 10 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
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Trial summary

This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of… Read more about this study

Who is it for?
Ages Up to 2 years
Conditions the study is for
Leukemia, Lymphoid
What is being tested?
Consolidation #4(without daunorubicin), Consolidation #4(with daunorubicin) and Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesSouth Korea
Study dates
11 Dec 2024to 31 Dec 2032
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 Up to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • The age of diagnosis is less than 1 year old
  • The disgnosisi of ALL or ALAL(lymphoid predominant)
  • Informed consent of the parents(guardians) before participation in this study

Who cannot join

  • Burkitt leukemia/lymphoma or mature B-cell leukemia
  • Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation
  • Relapsed infant leukemia
  • Participants with contraindication to medication
  • Administered systemic steroid therapy within 4 weeks prior to this study (However, steroid administration is allowable in oncologic emergencies only after the subject's disease diagnosis and risk group classification are completed.)
  • Participants in other interventional studies other than this protocol

Trial locations and contacts

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

10 sites in 1 country

South Korea10 sites, 10 recruiting

  • Kyungpook National University Chilgok-Hospital

    Daegu

    Ji Yoon Kim, Professor, phojyk@knu.ac.kr

    Not yet recruiting

  • Chungnam National University Hospital

    Daejeon

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

    Not yet recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun

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

    Recruiting

  • Jeju National University Hospital

    Jeju City

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

    Recruiting

  • Pusan National University Yangsan Hospital

    Pusan

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

    Recruiting

  • Asan Medical Center

    Seoul

    Ho Joon Im, MD, +82-2-3010-3371, hojim@amc.seoul.kr

    Recruiting

  • Samsung Medical Cente

    Seoul

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

    Recruiting

  • Seoul National University Hospital

    Seoul

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

    Recruiting

  • Seoul saint Mary's Hospital

    Seoul

    Jae Wook Lee, MD, +82-2-2258-6192, dashwood@catholic.ac.kr

    Recruiting

  • Severance Hospital

    Seoul

    seung min Hahn, MD, +82-2-2228-2050, bluenile88@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study

This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment.

In addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.

Read the detailed description

Infant leukemia patients are classified into low/intermediate/high risk groups and hematopoietic stem cell transplantation is performed after chemotherapy or chemotherapy as shown in the schema below.

  • Low risk group : Induction chemotherapy-Low Risk Consolidation chemotherapy 1~4 - Maintenance chemotherapy
  • Intermediate risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1~4 - Maintenance chemotherapy
  • High risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1~4 - hematopoietic stem cell transplantation
Being tested
Consolidation #4(without daunorubicin), Consolidation #4(with daunorubicin), Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)
Medical subject headings
Leukemia, Lymphoid

What participants receive

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

  • Consolidation #4(without daunorubicin)Drug

    1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate
    2. Low Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, intrathecal methotrexate
    3. Low Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate
    4. Low Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate
    5. Low Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate
    6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate

  • Consolidation #4(with daunorubicin)Drug

    1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate
    2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate
    3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate
    4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate
    5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate
    6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate

  • Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)Drug

    1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate
    2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate
    3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate
    4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate
    5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate
    6. Allogeneic hematopoietic stem cell transplantation
Study groups in NCT06516679
Study groupRoleWhat they receive
Low risk groupExperimentalKMT2A wild type \& minimal residual disease(MRD) (-) after consolidation 1
Receives: Drug: Consolidation #4(without daunorubicin)
Intermediate risk groupExperimentalntermediate risk (If one of the two cases below applies) * KMT2A: MLL mutation (+) \& minimal residual disease (MRD) (-) after consolidation 1 * KMT2A: wild type \& minimal residual disease (MRD) (+) after consolidation 1
Receives: Drug: Consolidation #4(with daunorubicin)
High risk groupExperimentalSomatic KMT2A mutation (+) \& minimal residual disease (MRD) (+) after consolidation 1
Receives: Drug: Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)

What is being measured

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

  1. 3-years Overall survival(OS) rate

    The 3-years overall survival rate defined as the percentage of subject in a treatment group who are alive three years after the start of treatm

    Measured: 3-years

Secondary outcomes (5)

  1. Overall survival (OS)

    The overall survival rate defined as the percentage of subject in a treatment group who are alive five years after the start of treatment.

    Measured: Up to 5years

  2. Event Free Survial(EFS)

    EFS is defined as the period from study enrollment until disease progression, including hematological recurrence of ALL, development of secondary malignancy, or death from any causes, whichever occurs earlier.

    Measured: 3-years and 5-years

  3. The rate of hematopoietic stem cell transplant patients by risk group

    through study completion, an average of 1 year

    Measured: Up to 5years

  4. recurred rate

    As a the period from enrollment to disease progression/recurrence

    Measured: Up to 5years

  5. Death rate related to infusion

    The time until defined by date of drug-related mortality from the date of 1st infusion

    Measured: Up to 5years

Timeline

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

  1. First posted24 Jul 2024
  2. Study start11 Dec 2024
  3. Primary completion31 Aug 2032 (estimated)
  4. Study completion31 Dec 2032 (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
Model description
* Low risk group : KMT2A wild type \& minimal residual disease(MRD) (-) after consolidation 1 * Intermediate risk group : Intermediate risk (If one of the two cases below applies) * KMT2A: MLL mutation (+) \& minimal residual disease (MRD) (-) after consolidation 1 * KMT2A: wild type \& minimal residual disease (MRD) (+) after consolidation 1 * High risk group : Somatic KMT2A mutation (+) \& minimal residual disease (MRD) (+) after consolidation 1
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06516679
Sponsor's protocol ID
4-2023-1263
Status last verified
Jul 2026
First submitted
27 Jun 2024
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Consolidation #4(without daunorubicin), Consolidation #4(with daunorubicin) and Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin) in people with Leukemia, Lymphoid, run by Yonsei University at 10 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?

The sponsor lists 3 inclusion and 6 exclusion criteria. 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 10 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-years Overall survival(OS) rate (time frame: 3-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 NCT06516679.

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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