Clinical trial · Interventional
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in
NCT06099366CI-TRIAL-00119776SR ALLrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoblastic Leukemia in Children | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate | Drug | — | UNRESOLVED |
| Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate | Drug | — | UNRESOLVED |
| Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate | Drug | — | UNRESOLVED |
| Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate | Drug | — | UNRESOLVED |
| induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate | Drug | — | UNRESOLVED |
| Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Standard-low (SL)
- description
- Induction-\> SL Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion-\> Interim Maintenance 2nd-\> Maintenance
- interventionNames
- Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
- Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
- Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
- Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
- Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
- type
- EXPERIMENTAL
- label
- Standard-average (SA)
- description
- Induction-\> SH Consolidation(4weeks)-\> Intensified Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion-\> Interim Maintenance 2nd-\> Maintenance
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 9 Years
Show eligibility criteria text
\<Inclusion Criteria\> * Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following 1. 1 year old ≤ Age \< 10 years old 2. white blood cell at initial diagnosis \< 5x10\^10/L (50,000uL) 3. No testis involvement 4. Satisfaction of following organ functions A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following: 1 to \< 2 years: Male: 0.6 / Female: 0.6, 2 to \< 6 years: Male: 0.8 / Female: 0.8, 6 to \< 10 years: Male: 1 / Female: 1, 10 to \< 13 years: Male: 1.2 / Female: 1.2, 13 to \< 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered. B. Liver function i. Direct bilirubin \< 3.0mg/dL \<Exclusion Criteria\> 1. Steroid administration within 2 weeks before the registration 2. t(9;22) or t(4;11)(q11;q23) or chromosome \< 44 or iAMP21 or t(17;19)/TCF3-HLF 3. Newly diagnosed T cell ALL 4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome 5. Burkitt leukemia/lymphoma 6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome 7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent
References
Publications (0)
Data not yet available
No reference posted for this study.