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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Severance Hospital |
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Clinical and genetic factors consistent with High risk : Induction → 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
Clinical and genetic factors consistent with High risk : Induction → 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALL, High risk with DI #2(Doxorubicin) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALL, High risk | Drug | Intervention Description :
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival | Event-free survival rate for 5 years from the date of registration | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The time until defined by date of all-cause mortality from the date of 1st infusion | Up to 5 years |
| Recurred rate | As the period from enrollment to disease progression/recurrence |
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<Inclusion Criteria>
Age: 1year~19years of age at diagnosis
Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
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.
<Exclusion Criteria>
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Wook Lee, Ph.D | Contact | 82-2-2258-6192 | dashwood@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jae Wook Lee, Ph.D | The Catholic University of Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C077194 | AIEOP acute lymphoblastic leukemia protocol |
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| OTHER |
| Pusan National University Yangsan Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
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|
| 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 | Up to 5 years |
| Samsung Medical Center | Recruiting | Seoul | Seoul | South Korea |
|
| Korea University Anam Hospital | Not yet recruiting | Seoul | 02841 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
|
| Seoul saint Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | 50612 | South Korea |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |