Evaluating the 2023 SIOP-Based Pediatric Acute Myeloid Leukemia Treatment Guidelines for Children Under 18 at Kamuzu Central Hospital, Malawi

What this Trial Is About

This research aims to evaluate the implementation of pediatric acute myeloid leukemia AML treatment guidelines adapted for resource-limited settings like Malawi. The study focuses on children under 18 years diagnosed with de novo AML at Kamuzu Central Hospital, where survival rates are notably low. It assesses a clinical practice guideline CPG based on recommendations by the International Society of Paediatric Oncology SIOP, designed to balance effective treatment with manageable side effects in this setting. The study observes patients treated according to the 2023 KCH AML therapy CPG, which is the current standard of care at the hospital. The guideline involves intensity-adapted chemotherapy cycles including induction and consolidation phases, with inpatient care during chemotherapy cycles until recovery milestones. Patients then have a brief home period before the next cycle. Data collection includes routine clinical care measurements like bone marrow evaluations, blood tests, imaging, and patient questionnaires, with no extra procedures required for study participation. Participants will be followed during therapy and after treatment completion, with monthly telephone check-ins for six months and in-person visits up to two years and beyond. The study measures implementation success by combining feasibility and effectiveness, including treatment completion rates and remission outcomes. Additional outcomes include survival, adverse events, hematologic recovery, cytogenetics, and quality of life assessments. This is the first prospective pediatric AML study in sub-Saharan Africa aimed at improving care in low-resource environments.

Leukemia Adapted Protocol