Interfant-06
Outcome of infants younger than 1 year with acute lymphoblastic leukemia treated with the Interfant-06 protocol: results from an international phase III randomized study
Phase 3N = 651NCT00550992
- Population
- Infants younger than 1 year with acute lymphoblastic leukemia (651 included).
- Design
- International phase III study by 18 national and international groups. Three risk groups: low risk (KMT2A germline), high risk (KMT2A-rearranged, older than 6 months, with WBC 300 x 10^9/L or more or a poor prednisone response) and medium risk (all other KMT2A-rearranged). Medium- and high-risk patients were randomly assigned to the lymphoid-style course IB (low-dose cytarabine, 6-mercaptopurine, cyclophosphamide) or to myeloid-style courses ADE (cytarabine, daunorubicin, etoposide) and MAE (mitoxantrone, cytarabine, etoposide). The role of stem-cell transplantation was also assessed.
- Arms
- All infants (risk-adapted protocol) (experimental, n = 651): Interfant-06 risk-adapted protocol
- Randomised: myeloid-style courses (experimental, n = 169): Cytarabine, daunorubicin, etoposide (ADE) and mitoxantrone, cytarabine, etoposide (MAE)
- Randomised: lymphoid-style course IB (control, n = 161): Low-dose cytarabine, 6-mercaptopurine, cyclophosphamide (IB)
- People
- Pieters R, senior author Valsecchi MG, Interfant study groups
Δ 72-month DFS+2.5 points
Show the numbers
| Endpoint | Analysis | All infants (risk-adapted protocol) / Randomised: myeloid-style courses | Randomised: lymphoid-style course IB | Effect |
|---|---|---|---|---|
| EFSAll infants included in the study (651)Event-free survival at 6 years, all infants included | finalPieters 2019 | 46.1% at 6 y | — | Standard error 2.1. |
| OSAll infants included in the study (651)Overall survival at 6 years, all infants included | finalPieters 2019 | 58.2% at 6 y | — | Standard error 2.0. |
| DFSMedium- and high-risk patients randomised to myeloid-style or lymphoid-style consolidation (n=169 and n=161)Probability of disease-free survival at 6 years in randomised patients | finalPieters 2019 | 39.3% at 6 y | 36.8% at 6 y | P=0.47Log-rank P. Standard errors 4.0 and 3.9. |
| Endpoint | Analysis | All infants (risk-adapted protocol) / Randomised: myeloid-style courses | Randomised: lymphoid-style course IB | Effect |
|---|---|---|---|---|
| EFSAll infants included in the study (651)Event-free survival at 6 years, all infants included | finalPieters 2019 | 46.1% at 6 y | — | Standard error 2.1. |
| OSAll infants included in the study (651)Overall survival at 6 years, all infants included | finalPieters 2019 | 58.2% at 6 y | — | Standard error 2.0. |
| DFSMedium- and high-risk patients randomised to myeloid-style or lymphoid-style consolidation (n=169 and n=161)Probability of disease-free survival at 6 years in randomised patients | finalPieters 2019 | 39.3% at 6 y | 36.8% at 6 y | P=0.47Log-rank P. Standard errors 4.0 and 3.9. |