Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
NCT ID: NCT06516679
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-12-11
2032-12-31
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
* 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
TREATMENT
NONE
Study Groups
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Low risk group
KMT2A wild type \& minimal residual disease(MRD) (-) after consolidation 1
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
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
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
High risk group
Somatic KMT2A mutation (+) \& minimal residual disease (MRD) (+) after consolidation 1
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
Interventions
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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
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
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
Eligibility Criteria
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Inclusion Criteria
* The disgnosisi of ALL or ALAL(lymphoid predominant)
* Informed consent of the parents(guardians) before participation in this study
Exclusion Criteria
* 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
* Participants in other interventional studies other than this protocol
2 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Pusan National University Yangsan Hospital
Pusan, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Cente
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul saint Mary's Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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4-2023-1263
Identifier Type: -
Identifier Source: org_study_id
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