Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

July 28, 2026 updated by: Yonsei University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

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 Locations

  • South Korea
      • Daegu, South Korea
        • Not yet recruiting
        • Kyungpook National University Chilgok-Hospital
        • Contact:
      • Daejeon, South Korea
        • 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
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Jeju City, South Korea
        • Recruiting
        • Jeju National University Hospital
        • Contact:
      • Pusan, South Korea
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul Saint Mary's Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Cente
        • Contact:

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:

  • 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

Exclusion Criteria:

  • 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

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: Low risk group
KMT2A wild type & minimal residual disease(MRD) (-) after consolidation 1
Drug: Consolidation #4(without daunorubicin)
  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
Experimental: Intermediate risk group

ntermediate 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
Drug: Consolidation #4(with daunorubicin)
  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
Experimental: High risk group
Somatic KMT2A mutation (+) & minimal residual disease (MRD) (+) after consolidation 1
Drug: Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)
  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-years Overall survival(OS) rate
Time Frame: 3-years
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
3-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 5years
The overall survival rate defined as the percentage of subject in a treatment group who are alive five years after the start of treatment.
Up to 5years
Event Free Survial(EFS)
Time Frame: 3-years and 5-years
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.
3-years and 5-years
The rate of hematopoietic stem cell transplant patients by risk group
Time Frame: Up to 5years
through study completion, an average of 1 year
Up to 5years
recurred rate
Time Frame: Up to 5years
As a the period from enrollment to disease progression/recurrence
Up to 5years
Death rate related to infusion
Time Frame: Up to 5years
The time until defined by date of drug-related mortality from the date of 1st infusion
Up to 5years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

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)

December 11, 2024

Primary Completion (Estimated)

August 31, 2032

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 24, 2024

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2023-1263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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