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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Samsung Medical Center | OTHER |
| Severance Hospital | OTHER |
| Pusan National University Yangsan Hospital |
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Very high-risk acute lymphoblastic leukemia
Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
If Minimal Residual Disease & qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine
If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab
Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3
M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Arm A, Dasatinib(Sprycel) Arm] | Experimental | ▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
|
|
| [Arm B, Non-Dasatinib(Sprycel) Arm] | Experimental | ▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib(Sprycel) arm | Drug | ▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)
|
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | 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:
Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyoung Jin Kang, Ph.D | Contact | +82-2-2072-3452 | kanghj@snu.ac.kr | |
| Hyoung Jin Kang | Contact | +82220723452 | kanghj@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | 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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| OTHER |
| Seoul St. Mary's Hospital | OTHER |
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|
| Non-Dasatinib(Sprycel) arm | Drug | ▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction
|
|
| 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 |
| Adverse Event | From Day 1 of the clinical trial to 28 days after last drug administration |
| The rate of Hematopoietic stem cell transplantation | The rate of Hematopoietic stem cell transplantation after the Induction and consolidation therapy | Up to 5 years |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| Seoul saint Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
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| Pusan National University Yangsan Hospital | Not yet recruiting | Yangsan | 50612 | South Korea |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |