Clinical trial · Interventional
Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children
NCT02339350CI-TRIAL-00016634unknownPhase 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)
Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%, thus recent studies focus on treatment intensification according to the risk group. According to the previous reports, we designed a multicenter prospective trial for pediatric ALL.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Child | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high dose methotrexate | Drug | Methotrexate | ALIAS |
| Intrathecal triple chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Rapid early responder group
- description
- 1. RER Consolidation BM exam on day 63: M1, M2 -\> IM M3 or residual CNS ds or Bx proven extramedullary ds - off protocol 2. RER Interim Maintenance #1 3. RER Delayed Intensification 4. RER Interim Maintenance #2 5. RER Maintenance (12 weeks=84 days)
- type
- EXPERIMENTAL
- label
- Slow early responder group
- description
- Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL 1\. SER Consolidation * Intrathecal triple chemotherapy at d0, 7, 14, 21 2. SER Interim Maintenance #1 * high dose methotrexate included * Intrathecal triple chemotherapy at d0, 28 3. SER Delayed Intensification #1 * Intrathecal triple chemotherapy at d0, 28, 35 4. SER Interim Maintenance #2 * high dose methotrexate included * Intrathecal triple chemotherapy at d0, 28 5. SER Delayed Intensification #2 * Intrathecal triple chemotherapy at d0, 28, 35 6. SER Maintenance * Intrathecal triple chemotherapy at d0
- interventionNames
- Drug: high dose methotrexate
- Drug: Intrathecal triple chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Diagnosis 1. Newly diagnosed B-precursor ALL meeting criteria 1.2 2. Newly diagnosed B-precursor ALL who was previously treated with steroid. 3. Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia 1.2 Initial WBC count 1. from 1 years old to 9 years old : WBC ≥ 50,000/μL 2. from 10 years old to 21 years old : Any WBC 3. from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3) Exclusion Criteria: 1. Philadelphia chromosome (+) or bcr/abl rearrangement (+) 2. Chromosome \<45 by cytogenetics 3. Induction failure (Day 28 M3 marrow (\>25% blasts)) 4. t(4:11) (as identified by cytogenetics, FISH or molecular studies) 5. Early T-cell precursor leukemia 6. Down syndrome ALL
References
Publications (0)
Data not yet available
No reference posted for this study.