International Acute Myeloid Leukemia Study

A therapy under development by a different sponsor had shown great promise for treating patients with AML. Despite its ability to move patients into remission, this initial treatment presented a high cardio-toxicity profile, making it unsafe for administration.

Our client was developing a therapy that when used in combination with the initial treatment eliminated the cardio-toxicity side effects. However, due to the risk of the known toxicity issues, the combination therapy needed to be tested outside of the U.S., and the client needed support planning a Phase I/II trial in Europe.

Catalyst Oncology was initially contracted to provide overall project management, as well as biometrics, medical monitoring, safety, and medical writing services. A separate contract research organization (CRO) was responsible for managing study startup and clinical monitoring services for sites in Italy and Poland.

Soon after the study began, it became evident that the other CRO was failing to file important study documentation while key milestones were being missed. Additionally, the lead principal investigator, after study commencement, ceased participating. With significant enrollment delays and the overall study in jeopardy, the Catalyst project team persuaded the client to allow Catalyst Oncology to assume responsibility for study startup and clinical operations activities in Italy and Poland.

Overall, Catalyst Oncology provided successful oversight of the study. Our hematology-oncology expertise combined with our in-depth operational knowledge, strong site relationships, and responsive, flexible approach enabled us to regain enrollment and get the study back on track.

The Phase I/II trial demonstrated zero cardio-toxicity effects, and the U.S. Food and Drug Administration approved a global pivotal Phase II/III trial of the combination therapy. As a result of our exceptional delivery on the Phase I/II trial, the client awarded the Phase II/III study to Catalyst Oncology uncontested. The study is expected to enroll 300+ patients across 50+ sites in 18+ countries, including the U.S. In all, we managed nine sites across Italy and Poland, enrolling 22 patients.