drugset / Trial / NCT05827549
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Phase 2
Recruiting
90 enrolled
Ho Joon Im
Chonnam National University Hospital · collabPusan National University Yangsan Hospital · collabSamsung Medical Center · collabSeoul National University Hospital · collabSeoul St. Mary's Hospital · collabSeverance Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.
Timeline
- Start
- 2024-04-04
- Primary completion
- 2032-12-31
- Completion
- 2032-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | 5 ug/m2 | — |
| Subject | Blinatumomab | Monoclonal antibody | 9 ug | — |
| Subject | Blinatumomab | Monoclonal antibody | 15 ug/m2 | — |
| Subject | Blinatumomab | Monoclonal antibody | 28 ug | — |
| Subject | Cytarabine | Small molecule | 1 g | Intrathecal |
| Subject | Cytarabine | Small molecule | 3000 mg/m2 | Intrathecal |
| Subject | Dexamethasone | Small molecule | 5 mg/m2 | — |
| Subject | Dexamethasone | Small molecule | 8 mg/m2 | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Idarubicin | Small molecule | 5 mg/m2 | — |
| Subject | Idarubicin | Small molecule | 10 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 1.8 g | — |
| Subject | Ifosfamide | Small molecule | 3.4 g | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 50 mg/m2 | Oral |
| Subject | Methotrexate | Small molecule | 20 mg/m2 | Intrathecal |
| Subject | Methotrexate | Small molecule | 25 mg/m2 | Intrathecal |
| Subject | Methotrexate | Small molecule | 500 mg/m2 | Intrathecal |
| Subject | Methotrexate | Small molecule | 1000 mg/m2 | Intrathecal |
| Subject | Prednisolone | Other / unclassified | 15 mg/m2 | — |
| Subject | Prednisolone | Other / unclassified | 60 mg/m2 | — |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | — |
| Subject | Vincristine | Small molecule | 2 mg/m2 | — |
| Subject | asparaginase | Protein / enzyme biologic | 6000 iu/kg | — |
| Subject | asparaginase | Protein / enzyme biologic | 10000 iu/kg | — |