Feasibility and Policy Implications of a Pragmatically Adapted Pediatric-Inspired Induction Regimen for Adults with Acute Lymphoblastic Leukemia in a Resource-Restricted Setting: A Prospective Observational Study.
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Background: Acute lymphoblastic leukemia (ALL) requires intensive induction, but implementation of pediatric-inspired regimens in low- and middle-income countries is constrained by diagnostic gaps, procurement instability, and limited supportive-care capacity. We evaluated the feasibility, safety, and affordability of a pragmatically adapted pediatric-inspired induction regimen for adults with Philadelphia chromosome-negative Ph(-) ALL in a Pakistani tertiary hospital. Methods: In this prospective single-center cohort study at the Pakistan Institute of Medical Sciences (December 2024-June 2025), consecutive adults aged 18-50 years with newly diagnosed Ph(-)ALL received an adapted pediatric-inspired induction regimen. The primary outcome was complete remission (CR) after induction, with or without extended induction. Secondary outcomes were early mortality, treatment abandonment, grade 3-4 toxicities, and service delivery feasibility indicators. Affordability was assessed against household income. Results: Among 200 adults (mean age 30.3 ± 8.8 years; 65.5% male), 39.5% presented with WBC ≥ 30 × 109/L and 88.0% with platelets < 50 × 103/µL. CR was achieved in 83.0% of patients. Early mortality was 2.0%, and treatment abandonment was 1.5%. Grade 3-4 toxicities included febrile neutropenia (15.0%) and sepsis (7.5%). The Day-30 evaluability was high (96.5%). Observed out-of-pocket diagnostic costs were USD 119, whereas a guideline-complete diagnostic package would cost USD 929, equivalent to 3-6 months of income for households in the poorest quintile. Conclusions: This adapted pediatric-inspired induction regimen was operationally deliverable in a resource-restricted hospital and produced favorable induction-phase outcomes. Limited diagnostic capacity and a lack of financial protection for testing remain barriers to risk-adapted care. Expanding subsidies for essential diagnostics and stabilizing the procurement of critical agents may yield the greatest implementation gains.