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Total 16

Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Phase 3NCT00549848

Population
Children and adolescents aged 0 to 18 years with newly diagnosed acute lymphoblastic leukemia; 598 patients
Design
Single-institution trial, 2007 to 2017, of risk-directed chemotherapy without prophylactic cranial irradiation in 598 consecutive patients aged 0 to 18 years. Of the 598, 414 were randomly assigned to PEG-asparaginase 3,500 U/m2 (206) or the conventional 2,500 U/m2 (208) (full text). Patients with features associated with increased risk of CNS relapse received two extra doses of intrathecal therapy in the first 2 weeks of induction; their CNS relapse rate was compared with patients with the same features treated in Total Therapy XV (not randomised).
Arms
  • Total Therapy 16 (experimental, n = 598): Risk-directed chemotherapy without prophylactic cranial irradiation; early intensification of triple intrathecal therapy for patients with features of increased CNS relapse risk
  • Total Therapy XV, same CNS-risk features (control, n = 248): Historical comparison group: Total Therapy XV patients with the same features associated with increased CNS relapse risk, without the two extra intrathecal doses
People
Jeha S, senior author Pui CH, St Jude Children's Research Hospital
Δ 60-month CNS relapse−3.9 points
Show the numbers
Results reported for Total 16
EndpointAnalysisTotal Therapy 16Total Therapy XV, same CNS-risk featuresEffect
EFSAll patients (598)primaryJeha 201988.2% at 5 y (84.9–91.5%)——
OSAll patients (598)primaryJeha 201994.1% at 5 y (91.7–96.5%)——
CNS relapseAll patients (598)Any CNS relapse, isolated or combinedprimaryJeha 20191.5% (0.5–2.5%)—5-year cumulative risk (Results section of the full text); the abstract sentence does not state the time horizon.
CNS relapsePatients with features associated with increased CNS-relapse risk (359 in Total Therapy 16; 248 in Total Therapy XV)Any CNS relapse, isolated or combinedprimaryJeha 20191.8% at 5 y (0.4–3.3%)5.7% at 5 y (2.8–8.6%)P=0.0085-year rate. Non-randomised comparison with an earlier study's patients; the two extra intrathecal doses were given to the Total Therapy 16 patients.
Results reported for Total 16
EndpointAnalysisTotal Therapy 16Total Therapy XV, same CNS-risk featuresEffect
EFSAll patients (598)primaryJeha 201988.2% at 5 y (84.9–91.5%)——
OSAll patients (598)primaryJeha 201994.1% at 5 y (91.7–96.5%)——
CNS relapseAll patients (598)Any CNS relapse, isolated or combinedprimaryJeha 20191.5% (0.5–2.5%)—5-year cumulative risk (Results section of the full text); the abstract sentence does not state the time horizon.
CNS relapsePatients with features associated with increased CNS-relapse risk (359 in Total Therapy 16; 248 in Total Therapy XV)Any CNS relapse, isolated or combinedprimaryJeha 20191.8% at 5 y (0.4–3.3%)5.7% at 5 y (2.8–8.6%)P=0.0085-year rate. Non-randomised comparison with an earlier study's patients; the two extra intrathecal doses were given to the Total Therapy 16 patients.
Primary publication: Jeha S, Pei D, Choi J, Cheng C, Sandlund JT, Coustan-Smith E, et al. Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16. J Clin Oncol. 2019;37(35):3377-3391. PubMedDOI

Appears in

Sources

  1. Jeha S, Pei D, Choi J, Cheng C, Sandlund JT, Coustan-Smith E, et al. Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16. J Clin Oncol. 2019;37(35):3377-3391.

    PubMedDOI