Turning Urgency Into Progress—Advancing New Hope In AML

When a Phase II trial in untreated acute myeloid leukemia (AML) was transferred mid-study from an underperforming CRO, nearly 130 enrolled patients across the U.S. and France faced the risk of lost momentum in a disease where every day counts. This case study explores how a coordinated, patient-centered transition stabilized operations without disrupting patients already on study. Real-time eligibility guidance helped sites navigate limited ATRA use at diagnosis, while optimized lab workflows cut genetic testing turnaround to just 1–2 days, keeping treatment decisions on pace. Hands-on site training improved consistency in sample handling and logistics, and low-burden tools like paper diaries made participation more manageable for an older patient population—all while data integrity was preserved for inspection readiness.

The trial reached Last Patient In on schedule, rebuilding sponsor confidence and leading to selection for a follow-on Phase III study. For trial teams facing a disrupted or underperforming study, this case demonstrates how rapid, clinically informed intervention can restore control, protect patient momentum, and turn a challenged trial into a foundation for continued development.