Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi

What this Trial Is About

This research aims to assess the use of an intensity-adapted clinical practice guideline (CPG) for treating pediatric acute myeloid leukemia (AML) in Malawi, where survival rates are low due to limited resources. The study evaluates the implementation of the International Society of Paediatric Oncology (SIOP) AML guidelines at Kamuzu Central Hospital (KCH) to improve outcomes by balancing effective treatment with manageable side effects in a real-world, resource-constrained setting. All children under 18 diagnosed with de novo AML at KCH will be treated following the 2023 KCH AML therapy CPG based on SIOP guidelines, which is the current standard of care. Patients receive chemotherapy cycles inpatient and undergo routine assessments including bone marrow tests, lumbar puncture, blood tests, and imaging. After treatment, patients are followed up by phone and in person at regular intervals up to and beyond two years to monitor health and quality of life. Participants will have data collected through standard clinical care without extra procedures from the study. Assessments include bone marrow evaluations, adverse event monitoring, patient-reported outcomes, and survival tracking. The main goal is to measure Implementation Success, combining treatment completion rates and remission rates, with secondary outcomes including survival, adverse events, and quality of life. This study will provide critical information to guide AML care in Malawi and similar low-resource settings.

Leukemia Adapted Protocol