Interfant-21: New trial for infants with ALL launched in Belgium

A new trial, Interfant-21, has been launched in September 2024. This trial will investigate an immunotherapy (blinatumomab) to improve outcome for infants (<1year) with KMT2A‐rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia.

Children younger than 1 year of age with acute lymphocytic leukemia (ALL) with KMT2A gene rearrangement have a poor prognosis with a higher risk of relapse of the disease and a lower survival after relapse. These children need innovative and new therapeutic agents to improve the outcome.

Blinatumomab, an immunotherapy, has been added as standard to chemotherapy treatment. Blinatumomab has far fewer side effects than chemotherapy and the results from a small study with this drug are very promising.

The primary objective of this study is to improve the outcome (in terms of event-free survival (EFS)) of newly diagnosed KMT2A-rearranged (KMT2A-r) infant acute lymphoblastic leukemia (ALL) compared with the historical results of the Interfant-06 protocol.

The international sponsor of the Interfant-21 trial is the Princess Maxima Center for Pediatric Oncology of Utrecht (The Netherland). In Belgium the study is coordinated by the Hôpital Universtitaire des Enfants Reine Fabiola (HUDERF), with Dr. Laurence Dedeken acting as the national coordinating investigator. All Belgian paediatric haematology-oncology centres are participating in this trial. For Belgium we expect to recruit 9 patients over a period of 3 years.

This trial is open in Belgium thanks to the financial support of both: