OnCo
trialsTrialMixed

Interfant-06

The largest infant leukaemia trial showed that intensifying chemotherapy did not help, and set the stage for adding blinatumomab instead.

651 infants; 6-year EFS 46.1% overall, no benefit from myeloid-style intensification; KMT2A rearrangement (in ~75%) remained the dominant adverse factor. JCO 2019. The follow-on Interfant-21 adds blinatumomab after a pilot (NEJM 2023) showed 2-year DFS 81.6% vs 49.4% historical, and menin inhibitors are entering infant ALL trials.

Setting
Infant ALL (<1 year): standard vs AML-type early intensification; transplant for high-risk KMT2A-rearranged infants
Phase
Phase 3
Sponsor
Interfant consortium
Registry
Headline result
6-year EFS 46.1%; intensification no benefit.
Reported
2019
Enrolled
651
Replication
COG AALL0631 reported similar EFS, confirming a plateau for chemotherapy-only approaches in infant ALL.

Outcomes

1top
In plain words
What these results mean for people, not percentages
651 people took part
Event-free survival at 6 yearsprimarysurrogate endpoint
  • 46.1 out of 100 people free of a major event at 6 years with All infants.
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Infant ALL (<1 year): standard vs AML-type early intensification; transplant for high-risk KMT2A-rearranged infants. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

651 participants enrolled.

Event-free survival at 6 yearsprimary
All infants46.1 of 100
n = 651
Source
EndpointArmnValueHR (95% CI)pSource
Event-free survival at 6 yearsprimaryAll infants65146.1%link
Replication
COG AALL0631 reported similar EFS, confirming a plateau for chemotherapy-only approaches in infant ALL.

Connected

6top