AALL0932
Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
Phase 3NCT01190930
- Population
- Children with newly diagnosed NCI standard-risk B-lymphoblastic leukemia; 2,364 average-risk patients randomised during maintenance
- Design
- COG phase 3 study enrolling 9,229 patients with NCI standard-risk B-ALL. Among them 2,364 average-risk patients were randomly assigned at the start of maintenance in a 2 x 2 factorial design to vincristine/dexamethasone pulses every 4 or every 12 weeks and to a starting dose of weekly oral methotrexate of 20 or 40 mg/m2. Disease-free survival and overall survival for the randomised comparisons are measured from the start of maintenance.
- Arms
- Vincristine/dexamethasone every 4 weeks (control, n = 1,186): Vincristine and dexamethasone pulses every 4 weeks during maintenance
- Vincristine/dexamethasone every 12 weeks (experimental, n = 1,178): Vincristine and dexamethasone pulses every 12 weeks during maintenance
- Methotrexate 20 mg/m2 (control): Weekly oral methotrexate, starting dose 20 mg/m2
- Methotrexate 40 mg/m2 (experimental): Weekly oral methotrexate, starting dose 40 mg/m2
- People
- Angiolillo AL, senior author Hunger SP, Children's Oncology Group
Δ 60-month DFS+1 pointsΔ 60-month OS+0.3 pointsΔ 60-month DFS−0.9 pointsΔ 60-month OS−0.7 points
Show the numbers
| Endpoint | Analysis | Vincristine/dexamethasone every 12 weeks / Methotrexate 40 mg/m2 | Vincristine/dexamethasone every 4 weeks / Methotrexate 20 mg/m2 | Effect |
|---|---|---|---|---|
| DFSAverage-risk patients randomised to vincristine/dexamethasone frequency | primaryAngiolillo 2021 | 95.1% at 5 y (93.3–96.9%) | 94.1% at 5 y (92.2–96.0%) | P=.865-year DFS from the start of maintenance. Allocation to the methotrexate dose was crossed with this comparison (2 x 2 factorial). |
| OSAverage-risk patients randomised to vincristine/dexamethasone frequency | primaryAngiolillo 2021 | 98.6% at 5 y (97.7–99.6%) | 98.3% at 5 y (97.2–99.4%) | P=.695-year OS from the start of maintenance. |
| DFSAverage-risk patients randomised to methotrexate starting dose | primaryAngiolillo 2021 | 94.2% at 5 y (92.2–96.1%) | 95.1% at 5 y (93.3–96.8%) | P=.925-year DFS from the start of maintenance. Allocation to vincristine/dexamethasone frequency was crossed with this comparison. |
| OSAverage-risk patients randomised to methotrexate starting dose | primaryAngiolillo 2021 | 98.1% at 5 y (97.0–99.2%) | 98.8% at 5 y (97.9–99.7%) | P=.895-year OS from the start of maintenance. |
| Endpoint | Analysis | Vincristine/dexamethasone every 12 weeks / Methotrexate 40 mg/m2 | Vincristine/dexamethasone every 4 weeks / Methotrexate 20 mg/m2 | Effect |
|---|---|---|---|---|
| DFSAverage-risk patients randomised to vincristine/dexamethasone frequency | primaryAngiolillo 2021 | 95.1% at 5 y (93.3–96.9%) | 94.1% at 5 y (92.2–96.0%) | P=.865-year DFS from the start of maintenance. Allocation to the methotrexate dose was crossed with this comparison (2 x 2 factorial). |
| OSAverage-risk patients randomised to vincristine/dexamethasone frequency | primaryAngiolillo 2021 | 98.6% at 5 y (97.7–99.6%) | 98.3% at 5 y (97.2–99.4%) | P=.695-year OS from the start of maintenance. |
| DFSAverage-risk patients randomised to methotrexate starting dose | primaryAngiolillo 2021 | 94.2% at 5 y (92.2–96.1%) | 95.1% at 5 y (93.3–96.8%) | P=.925-year DFS from the start of maintenance. Allocation to vincristine/dexamethasone frequency was crossed with this comparison. |
| OSAverage-risk patients randomised to methotrexate starting dose | primaryAngiolillo 2021 | 98.1% at 5 y (97.0–99.2%) | 98.8% at 5 y (97.9–99.7%) | P=.895-year OS from the start of maintenance. |
Appears in
Sources
Angiolillo AL, Schore RJ, Kairalla JA, Devidas M, Rabin KR, Zweidler-McKay P, et al. Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932. J Clin Oncol. 2021;39(13):1437-1447.