Outcomes of Childhood Acute Lymphoblastic Leukemia Treated with Modified BFM-2009 Protocol Using Measurable Residual...

Chemotherapeutic protocols developed in high-income countries do not produce comparable results in low- and lower-middle income countries (LMICs). This study analyzed the treatment outcomes of modified Berlin-Frankfurt-Munster (BFM)-2009 protocol in children with acute lymphoblastic leukemia (ALL) in a tertiary care referral center in Northern India.

This retrospective study evaluated the treatment outcomes of children with newly diagnosed ALL treated with the modified BFM-2009 protocol using a risk-stratified approach between July 2018 and Dec 2024 and followed-up till June 2025.

One hundred sixty six children with a median (q1, q3) age 51 (31, 78) months were followed-up over a median (range) duration of 36.5 (6-84) months. Patients were categorized as standard-risk (SR, 34%), intermediate-risk (IR, 36%) and high-risk (HR, 30%). Extra-medullary disease was seen in 1 child and T-cell lineage in 27 (16%). On day 8, 13 out of 160 children (8%) had prednisolone poor response (PPR). At end of induction-I, 159 out of 160 patients were in morphological remission (marrow blasts < 5%) and measurable residual disease (MRD) was positive in 23 out of 156 (14.7%). At the end of re-intensification phase (induction-II), MRD was positive in 5 children. Relapse and overall toxic deaths were seen in 16/166 (9.6%) and 8/162 (4.9%) children. Event-free survival (EFS) and overall survival (OS) at 36-month follow-up for SR, IR and HR were 95.7% and 96.5%, 83% and 85%, 76.9% and 79%, respectively. Children with PPR and IR/HR were associated with poor EFS.

Adapting, rather than, adopting a protocol in LMICs, improves outcomes for childhood ALL.