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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low risk group | Experimental | KMT2A wild type & minimal residual disease(MRD) (-) after consolidation 1 |
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| Intermediate risk group | Experimental | ntermediate risk (If one of the two cases below applies)
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| High risk group | Experimental | Somatic KMT2A mutation (+) & minimal residual disease (MRD) (+) after consolidation 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consolidation #4(without daunorubicin) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5years |
| Event Free Survial(EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | South Korea |
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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
High risk group : Somatic KMT2A mutation (+) & minimal residual disease (MRD) (+) after consolidation 1
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| Consolidation #4(with daunorubicin) | Drug |
|
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| Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin) | Drug |
|
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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 | through study completion, an average of 1 year | Up to 5years |
| recurred rate | As a the period from enrollment to disease progression/recurrence | Up to 5years |
| Death rate related to infusion | The time until defined by date of drug-related mortality from the date of 1st infusion | Up to 5years |
| Jeju National University Hospital | Recruiting | Jeju City | South Korea |
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| Pusan National University Yangsan Hospital | Recruiting | Pusan | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Samsung Medical Cente | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| Seoul saint Mary's Hospital | Recruiting | Seoul | South Korea |
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| Severance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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