Treatment of Pediatric Acute Lymphoblastic Leukemia in India as per modified BFM 95 protocol with Minimal Residual Disease monitoring

Background: Survival outcomes of Pediatric Acute Lymphoblastic Leukemia (ALL) in the developing world have lagged. Here we report improved outcomes of pediatric ALL from India.Methods: We analyzed outcomes of children with ALL treated at our center between 2016 and 2021. They were treated as per the modified BFM 95 protocol with Minimal Residual Disease (MRD) monitoring by flow cytometry (FCM).Results: We diagnosed and managed 68 patients, 57 being Precursor B (Pre B) cell ALL and the rest of T cell ALL. With BFM 95 protocol-based risk stratification, 19/68, 44/68 and 3/68 patients were Standard risk (SR), Medium risk (MR) and High risk (HR), respectively and 2/68 were not stratified due to Induction mortality. With MRD-based risk stratification, 52/68, 11/68 and 2/68 patients fell in the SR, MR and HR category, respectively and 3/68 patients were not classifiable by MRD (2 Induction deaths and 1 refractory disease) and 65/68 patients achieved morphological complete remission (CR) at the end of Induction. Five out of 68 ALL patients underwent allogeneic hematopoietic stem cell transplant (HSCT) in CR1. Ten out of 68 patients had a relapse, 6 of whom are alive and in CR2 till the last follow-up. The mean duration of follow-up was 1150 days (median 1219 days). Treatment-related mortality was 4.4% in our cohort. The Event Free Survival (EFS) of our cohort was 79.4% and Overall Survival (OS) was 88.2% at a median follow-up of 1219 days.Conclusion: Survival outcomes have improved for children with ALL with modifications in BFM 95 protocol and incorporation of MRD assessment.