AALL1731
A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)
Phase 3NCT03914625
- Population
- Children with newly diagnosed NCI standard-risk B-cell acute lymphoblastic leukemia and average or higher risk of relapse
- Design
- Phase 3 randomised trial in children with newly diagnosed NCI standard-risk B-cell ALL and average or higher risk of relapse: chemotherapy alone or chemotherapy plus two nonsequential 28-day cycles of blinatumomab. Standard risk here is age 1 to under 10 years with white-cell count below 50,000/microL; children with Down syndrome were eligible and 32 (16 per arm) are among those randomised in the average-risk stratum. Results shown are the first interim efficacy analysis (1440 randomised), after which the data and safety monitoring committee recommended early termination of randomisation.
- Primary endpoint
- DFS
- Arms
- Chemotherapy alone (control, n = 722): Combination chemotherapy
- Blinatumomab plus chemotherapy (experimental, n = 718): Combination chemotherapy plus two nonsequential 28-day cycles of blinatumomab
- People
- Gupta S, senior author Loh ML, Children's Oncology Group
Δ 36-month DFS+8.1 pointsΔ 36-month DFS+7.3 pointsΔ 36-month DFS+9.3 points
Show the numbers
| Endpoint | Analysis | Blinatumomab plus chemotherapy | Chemotherapy alone | Effect |
|---|---|---|---|---|
| DFSPatients randomised at the first interim efficacy analysis (1440) | interimmedian follow-up 2.5 yearsGupta 2025 | 96% at 3 y | 87.9% at 3 y | P<0.001Estimated 3-year DFS is given with standard errors, not confidence intervals: 96.0 (SE 1.2) with blinatumomab and 87.9 (SE 2.1) with chemotherapy alone. The abstract reports a difference in restricted mean survival time of 72 days (95% CI 36 to 108); P by stratified log-rank test. |
| DFSPatients with average relapse risk | interimmedian follow-up 2.5 yearsGupta 2025 | 97.5% at 3 y | 90.2% at 3 y | Standard errors: 97.5 (SE 1.3) with blinatumomab, 90.2 (SE 2.3) with chemotherapy alone. Subgroup; no test reported in the abstract. |
| DFSPatients with higher relapse risk | interimmedian follow-up 2.5 yearsGupta 2025 | 94.1% at 3 y | 84.8% at 3 y | Standard errors: 94.1 (SE 2.5) with blinatumomab, 84.8 (SE 3.8) with chemotherapy alone. Subgroup; no test reported in the abstract. |
| Endpoint | Analysis | Blinatumomab plus chemotherapy | Chemotherapy alone | Effect |
|---|---|---|---|---|
| DFSPatients randomised at the first interim efficacy analysis (1440) | interimmedian follow-up 2.5 yearsGupta 2025 | 96% at 3 y | 87.9% at 3 y | P<0.001Estimated 3-year DFS is given with standard errors, not confidence intervals: 96.0 (SE 1.2) with blinatumomab and 87.9 (SE 2.1) with chemotherapy alone. The abstract reports a difference in restricted mean survival time of 72 days (95% CI 36 to 108); P by stratified log-rank test. |
| DFSPatients with average relapse risk | interimmedian follow-up 2.5 yearsGupta 2025 | 97.5% at 3 y | 90.2% at 3 y | Standard errors: 97.5 (SE 1.3) with blinatumomab, 90.2 (SE 2.3) with chemotherapy alone. Subgroup; no test reported in the abstract. |
| DFSPatients with higher relapse risk | interimmedian follow-up 2.5 yearsGupta 2025 | 94.1% at 3 y | 84.8% at 3 y | Standard errors: 94.1 (SE 2.5) with blinatumomab, 84.8 (SE 3.8) with chemotherapy alone. Subgroup; no test reported in the abstract. |