Clinical trial · Interventional
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
NCT00137111CI-TRIAL-00047117completedPhase 3Results postedClinicalTrials.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 primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.
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, Acute | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy, intrathecal chemotherapy | Procedure | — | UNRESOLVED |
| Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase | Drug | — | UNRESOLVED |
| Mercaptopurine, Imatinib | Drug | — | UNRESOLVED |
| Methotrexate, Cyclophosphamide, Cytarabine, Etoposide | Drug | — | UNRESOLVED |
| Prednisone, Dexamethasone, Vincristine, Daunorubicin | Drug | — | UNRESOLVED |
| steroid therapy, hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin
- Drug: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
- Drug: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
- Drug: Mercaptopurine, Imatinib
- Procedure: chemotherapy, intrathecal chemotherapy
- Procedure: steroid therapy, hematopoietic stem cell transplantation
- type
- OTHER
- label
- 2
- interventionNames
- Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin
- Drug: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
- Drug: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
- Drug: Mercaptopurine, Imatinib
- Procedure: chemotherapy, intrathecal chemotherapy
- Procedure: steroid therapy, hematopoietic stem cell transplantation
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of non-B-cell ALL by immunophenotyping, as determined by the reactivity pattern to a panel of monoclonal antibodies with flow cytometry as well as morphology and cytochemical staining. * Age range: 1 to 18 years (inclusive). Exclusion Criteria: • Previously treated with chemotherapy for one week or longer.
References
Publications (207)
- BACKGROUNDYeoh EJ, Ross ME, Shurtleff SA, Williams WK, Patel D, Mahfouz R, Behm FG, Raimondi SC, Relling MV, Patel A, Cheng C, Campana D, Wilkins D, Zhou X, Li J, Liu H, Pui CH, Evans WE, Naeve C, Wong L, Downing JR. Classification, subtype discovery, and prediction of outcome in pediatric acute lymphoblastic leukemia by gene expression profiling. Cancer Cell. 2002 Mar;1(2):133-43. doi: 10.1016/s1535-6108(02)00032-6. PMID 12086872
- BACKGROUNDCoustan-Smith E, Sancho J, Hancock ML, Razzouk BI, Ribeiro RC, Rivera GK, Rubnitz JE, Sandlund JT, Pui CH, Campana D. Use of peripheral blood instead of bone marrow to monitor residual disease in children with acute lymphoblastic leukemia. Blood. 2002 Oct 1;100(7):2399-402. doi: 10.1182/blood-2002-04-1130. PMID 12239148
- BACKGROUNDCheok MH, Yang W, Pui CH, Downing JR, Cheng C, Naeve CW, Relling MV, Evans WE. Treatment-specific changes in gene expression discriminate in vivo drug response in human leukemia cells. Nat Genet. 2003 May;34(1):85-90. doi: 10.1038/ng1151. PMID 12704389
- BACKGROUNDNeale GA, Coustan-Smith E, Stow P, Pan Q, Chen X, Pui CH, Campana D. Comparative analysis of flow cytometry and polymerase chain reaction for the detection of minimal residual disease in childhood acute lymphoblastic leukemia. Leukemia. 2004 May;18(5):934-8. doi: 10.1038/sj.leu.2403348. PMID 15029212
- BACKGROUNDPauley JL, Panetta JC, Schmidt J, Kornegay N, Relling MV, Pui CH. Late-onset delayed excretion of methotrexate. Cancer Chemother Pharmacol. 2004 Aug;54(2):146-52. doi: 10.1007/s00280-004-0797-y. Epub 2004 May 18. PMID 15148625
- BACKGROUNDPui CH, Relling MV, Sandlund JT, Downing JR, Campana D, Evans WE. Rationale and design of Total Therapy Study XV for newly diagnosed childhood acute lymphoblastic leukemia. Ann Hematol. 2004;83 Suppl 1:S124-6. doi: 10.1007/s00277-004-0850-2. PMID 15124703