Total XV
Total XV - Total Therapy Study XV for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Phase 3NCT00137111
- Population
- Children with newly diagnosed acute lymphoblastic leukemia; 498 evaluable patients
- Design
- Trial run at St Jude Children's Research Hospital (411 patients) and Cook Children's Medical Center (90), June 2000 to October 2007, testing whether prophylactic cranial irradiation can be omitted in all children with newly diagnosed ALL. Treatment intensity was based on presenting features and minimal residual disease after remission induction. The only comparison relevant to irradiation is with 56 historical controls who received prophylactic cranial irradiation (not randomised).
- Arms
- Total Therapy XV (experimental, n = 498): Risk-adapted chemotherapy without prophylactic cranial irradiation; intensity set by presenting features and minimal residual disease after remission induction
- Historical controls with irradiation (control, n = 56): Earlier patients who received prophylactic cranial irradiation, used for comparison with the 71 patients who would previously have been irradiated
- People
- Pui CH, senior author Relling MV
Show the numbers
| Endpoint | Analysis | Total Therapy XV | Historical controls with irradiation | Effect |
|---|---|---|---|---|
| EFSAll evaluable patients (498) | primaryPui 2009 | 85.6% at 5 y (79.9–91.3%) | — | — |
| OSAll evaluable patients (498) | primaryPui 2009 | 93.5% at 5 y (89.8–97.2%) | — | — |
| Isolated CNS relapseAll evaluable patients (498) | primaryPui 2009 | 2.7% at 5 y (1.1–4.3%) | — | 5-year cumulative risk. Eleven patients had an isolated CNS relapse; all remained in second remission for 0.4 to 5.5 years. |
| CNS relapseAll evaluable patients (498)Any CNS relapse, isolated or combined with relapse elsewhere | primaryPui 2009 | 3.9% at 5 y (1.9–5.9%) | — | 5-year cumulative risk of any CNS relapse (isolated and combined). |
| Endpoint | Analysis | Total Therapy XV | Historical controls with irradiation | Effect |
|---|---|---|---|---|
| EFSAll evaluable patients (498) | primaryPui 2009 | 85.6% at 5 y (79.9–91.3%) | — | — |
| OSAll evaluable patients (498) | primaryPui 2009 | 93.5% at 5 y (89.8–97.2%) | — | — |
| Isolated CNS relapseAll evaluable patients (498) | primaryPui 2009 | 2.7% at 5 y (1.1–4.3%) | — | 5-year cumulative risk. Eleven patients had an isolated CNS relapse; all remained in second remission for 0.4 to 5.5 years. |
| CNS relapseAll evaluable patients (498)Any CNS relapse, isolated or combined with relapse elsewhere | primaryPui 2009 | 3.9% at 5 y (1.9–5.9%) | — | 5-year cumulative risk of any CNS relapse (isolated and combined). |