AALL0232
Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Phase 3N = 3,154NCT00075725
- Population
- Participants aged 1 to 30 years with newly diagnosed high-risk B-acute lymphoblastic leukemia
- Design
- COG phase 3 trial, January 2004 to January 2011, in participants aged 1 to 30 years with newly diagnosed high-risk B-ALL: 3,154 enrolled and 2,914 randomised in a 2 x 2 factorial design to dexamethasone (14 days) versus prednisone (28 days) during induction, and to high-dose methotrexate versus Capizzi escalating-dose methotrexate plus pegaspargase during interim maintenance 1. Randomisation to the corticosteroid comparison excluded participants 10 years and older from 2008. Enrolment stopped in January 2011 after planned interim monitoring showed the high-dose methotrexate regimens exceeded the predefined superiority boundary.
- Arms
- Capizzi methotrexate plus pegaspargase (control): Capizzi escalating-dose methotrexate plus pegaspargase during interim maintenance 1
- High-dose methotrexate (experimental): High-dose methotrexate during interim maintenance 1
- Prednisone (28 days) (control): Prednisone for 28 days during induction
- Dexamethasone (14 days) (experimental): Dexamethasone for 14 days during induction
- People
- Larsen EC, senior author Carroll WL, Children's Oncology Group
Δ 60-month EFS+6.6 pointsΔ 60-month EFS+4.4 points
Show the numbers
| Endpoint | Analysis | High-dose methotrexate / Dexamethasone (14 days) | Capizzi methotrexate plus pegaspargase / Prednisone (28 days) | Effect |
|---|---|---|---|---|
| EFSParticipants randomised to the interim maintenance 1 comparison, at the time enrolment stopped (January 2011) | interimLarsen 2016 | 82% at 5 y | 75.4% at 5 y | P=.006Planned interim monitoring result that stopped enrolment. |
| EFSParticipants randomised to the interim maintenance 1 comparison, mature final data | finalLarsen 2016 | 79.6% at 5 y | 75.2% at 5 y | P=.008Mature final data. The abstract states that high-dose methotrexate decreased both marrow and CNS recurrences. |
| Endpoint | Analysis | High-dose methotrexate / Dexamethasone (14 days) | Capizzi methotrexate plus pegaspargase / Prednisone (28 days) | Effect |
|---|---|---|---|---|
| EFSParticipants randomised to the interim maintenance 1 comparison, at the time enrolment stopped (January 2011) | interimLarsen 2016 | 82% at 5 y | 75.4% at 5 y | P=.006Planned interim monitoring result that stopped enrolment. |
| EFSParticipants randomised to the interim maintenance 1 comparison, mature final data | finalLarsen 2016 | 79.6% at 5 y | 75.2% at 5 y | P=.008Mature final data. The abstract states that high-dose methotrexate decreased both marrow and CNS recurrences. |