Clinical trial · Interventional
A Study of Children With Refractory or Relapsed ALL
A Study of Children With Refractory or Relapsed Acute Lymphoblastic Leukemia (ALLR16)
NCT00187083CI-TRIAL-00001509completedPhase 3ClinicalTrials.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)
The main purpose of this study is to find out which form of asparaginase (the native E. coli/Erwinia) or PEG-asparaginase) is more effective during induction treatment for children with acute lymphoblastic leukemia that has come back after treatment (relapsed) or is resistant to treatment (refractory)
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy, intrathecal chemotherapy, steroid therapy | Procedure | — | UNRESOLVED |
| E. coli Asparaginase, PEG-L-asparaginase | Drug | — | UNRESOLVED |
| erwinia asparaginase | Drug | — | UNRESOLVED |
| fludarabine, methotrexate, mercaptopurine | Drug | — | UNRESOLVED |
| idarubicin, etoposide, cytarbine, teniposide | Drug | — | UNRESOLVED |
| Topotecan, dexamethasone, vincristine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Native asparaginase
- interventionNames
- Drug: Topotecan, dexamethasone, vincristine
- Drug: E. coli Asparaginase, PEG-L-asparaginase
- Drug: erwinia asparaginase
- Drug: fludarabine, methotrexate, mercaptopurine
- Drug: idarubicin, etoposide, cytarbine, teniposide
- Procedure: chemotherapy, intrathecal chemotherapy, steroid therapy
- type
- EXPERIMENTAL
- label
- 2
- description
- PEG-asparaginase
- interventionNames
- Drug: Topotecan, dexamethasone, vincristine
- Drug: E. coli Asparaginase, PEG-L-asparaginase
- Drug: erwinia asparaginase
- Drug: fludarabine, methotrexate, mercaptopurine
- Drug: idarubicin, etoposide, cytarbine, teniposide
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria For patients treated on frontline protocols at St. Jude: * ALL in isolated bone marrow relapse, or combined marrow and extramedullary relapse, during or after treatment with multi-agent chemotherapy (TOTAL XI, XII, XIIIA, XIIIB), or isolated extramedullary relapse after treatment on TOTXII. * Patients with recurrent T-Cell non-Hodgkin's lymphoma who relapse in the bone marrow with \>25% blasts For patients not treated on front-line St. Jude protocols: • ALL in isolated bone marrow relapse, or isolated extramedullary relapse, or combined marrow and extramedullary relapse. All patients: * First relapse after receiving primary therapy or during primary therapy * Life expectance of at least 8 weeks * ECOG score 0-2 Exclusion criteria * Life expectancy \< 8 weeks
References
Publications (0)
Data not yet available
No reference posted for this study.