Safety and Efficacy of Blinatumomab Combined with Standard Chemotherapy in Infants with KMT2A-Rearranged Acute Lymphoblastic Leukemia: A Promising Approach"

Adding a Blinatumomab by specific TCell engager targetting CD-19 to standard chemotherapy would be safe and efficacious in these infants?

Infants with Lymphoblastic Leukaemia have a poor prognosis, particularly with Histone-lysine N-methyltransferase 2A or KMT2A gene rearrangement in which 6 year event free survival is less than 40%.

Abstract from study titled Blinatumomab Added to Chemotherapy in Infant Lymphoblastic Leukaemia.

In the new study of safety and efficacy of blinatumomab, a bispecific T-cell engager molecule targeting CD19, in infants with KMT2A-rearranged ALL.

In this phase 2 multinational prospective single group study 30 infants older than 1 year of age with acute Lymphoblastic Leukaemia and a KMT2A gene rearrangement received 1 month of chemotherapy followed by continuous 4-week infusion of Blinatumomab patient still resumes (protocol IB, MARMA, HSCT, or OCTODAD plus maintenance therapy). 

The primary end point was incidence of clinically relevant toxic effects. Any toxic effect possibly or definitely attributable to blinatumomab, that led to permanent discontinuation or death.

All 30 patients received the full course of blinatumomab and no clinically relevant toxic effects occurred. However, 10 serious events were reported in 9 patients.

After blinatumomab infusion, molecular testing detected Leukemic Cells in 53%, whereas no leukemic cells in 40%.During a median 26 months follow up two year disease free survival was 81.6% and two year overall survival was 93.3%.

The author concluded that in infants younger than 1 year of age with Acute Lymphoblastic Leukaemia KMT2A gene rearrangement Blinatumomab to standard chemotherapy appeared safe and highly efficacious.