Blinatumomab added to Interfant-06 chemotherapy in infants with newly diagnosed KMT2A-rearranged acute lymphoblastic leukemia
N = 30
- Population
- Infants younger than 1 year with newly diagnosed KMT2A-rearranged ALL.
- Design
- Single-arm study. Thirty infants younger than 1 year with newly diagnosed KMT2A-rearranged ALL received Interfant-06 chemotherapy plus one post-induction course of blinatumomab (15 µg/m2 body-surface area per day, 28-day continuous infusion). Primary end point: clinically relevant toxic effects. MRD measured by polymerase chain reaction. Outcomes compared with historical Interfant-06 controls. EudraCT 2016-004674-17; no ClinicalTrials.gov record found by the project.
- Primary endpoint
- Clinically relevant toxic effects
- Arms
- Chemotherapy plus blinatumomab (experimental, n = 30): Interfant-06 chemotherapy plus one 28-day post-induction blinatumomab course (15 µg/m2/day)
- Interfant-06 (historical) (control): Interfant-06 chemotherapy without blinatumomab (historical control data; selection described as 'Interfant-06-selected' in the 2026 follow-up)
- People
- van der Sluis IM, senior author Pieters R
Δ 24-month DFS+32.2 pointsΔ 24-month OS+27.5 pointsΔ 48-month DFS+39.3 pointsΔ 48-month OS+33.1 points
Show the numbers
| Endpoint | Analysis | Chemotherapy plus blinatumomab | Interfant-06 (historical) | Effect |
|---|---|---|---|---|
| DFSAll 30 patients, compared with historical controls from the Interfant-06 trialDisease-free survival at 2 years | primarymedian follow-up 26.3 monthsvan 2023 | 81.6% at 2 y (60.8–92.0%) | 49.4% at 2 y (42.5–56.0%) | No P value is given in the abstract. Comparison with historical controls, not randomised. |
| OSAll 30 patients, compared with historical controls from the Interfant-06 trialOverall survival at 2 years | primarymedian follow-up 26.3 monthsvan 2023 | 93.3% at 2 y (75.9–98.3%) | 65.8% at 2 y (58.9–71.8%) | No P value is given in the abstract. Comparison with historical controls, not randomised. |
| DFS30 infants compared with 214 selected Interfant-06 controls not receiving blinatumomab (selected by this study's inclusion criteria, with end-of-induction MRD data available)Disease-free survival at 4 years | long term-updatemedian follow-up 4.2 yearsVieira 2026 | 83.3% at 4 y (64.5–92.7%) | 44% at 4 y (37.0–50.8%) | The abstract states a significant improvement versus controls; neither abstract nor full text gives a P value. Confidence intervals are from the full text. Median follow-up 4.2 years (range 3.2-6.0). |
| OS30 infants compared with 214 selected Interfant-06 controls not receiving blinatumomab (selected by this study's inclusion criteria, with end-of-induction MRD data available)Overall survival at 4 years | long term-updatemedian follow-up 4.2 yearsVieira 2026 | 93.3% at 4 y (75.9–98.3%) | 60.2% at 4 y (53.0–66.7%) | The abstract states a significant improvement versus controls; neither abstract nor full text gives a P value. Confidence intervals are from the full text. Median follow-up 4.2 years (range 3.2-6.0). |
| Endpoint | Analysis | Chemotherapy plus blinatumomab | Interfant-06 (historical) | Effect |
|---|---|---|---|---|
| DFSAll 30 patients, compared with historical controls from the Interfant-06 trialDisease-free survival at 2 years | primarymedian follow-up 26.3 monthsvan 2023 | 81.6% at 2 y (60.8–92.0%) | 49.4% at 2 y (42.5–56.0%) | No P value is given in the abstract. Comparison with historical controls, not randomised. |
| OSAll 30 patients, compared with historical controls from the Interfant-06 trialOverall survival at 2 years | primarymedian follow-up 26.3 monthsvan 2023 | 93.3% at 2 y (75.9–98.3%) | 65.8% at 2 y (58.9–71.8%) | No P value is given in the abstract. Comparison with historical controls, not randomised. |
| DFS30 infants compared with 214 selected Interfant-06 controls not receiving blinatumomab (selected by this study's inclusion criteria, with end-of-induction MRD data available)Disease-free survival at 4 years | long term-updatemedian follow-up 4.2 yearsVieira 2026 | 83.3% at 4 y (64.5–92.7%) | 44% at 4 y (37.0–50.8%) | The abstract states a significant improvement versus controls; neither abstract nor full text gives a P value. Confidence intervals are from the full text. Median follow-up 4.2 years (range 3.2-6.0). |
| OS30 infants compared with 214 selected Interfant-06 controls not receiving blinatumomab (selected by this study's inclusion criteria, with end-of-induction MRD data available)Overall survival at 4 years | long term-updatemedian follow-up 4.2 yearsVieira 2026 | 93.3% at 4 y (75.9–98.3%) | 60.2% at 4 y (53.0–66.7%) | The abstract states a significant improvement versus controls; neither abstract nor full text gives a P value. Confidence intervals are from the full text. Median follow-up 4.2 years (range 3.2-6.0). |
Appears in
Sources
van der Sluis IM, de Lorenzo P, Kotecha RS, Attarbaschi A, Escherich G, Nysom K, et al. Blinatumomab Added to Chemotherapy in Infant Lymphoblastic Leukemia. N Engl J Med. 2023;388(17):1572-1581.
Vieira Martins M, de Lorenzo P, Kotecha RS, Attarbaschi A, Escherich G, Nysom K, et al. Sustained Benefit of Blinatumomab in Infants With KMT2A-Rearranged ALL: Long-Term Outcomes, Toxicity, and Pharmacokinetics. J Clin Oncol. 2026;44(5):370-374.