The Leukemia & Lymphoma Society (LLS) has selected INC Research to manage its recently-launched precision medicine Master Trial to treat acute myeloid leukemia (AML). The Beat AML Master Trial is the first time a non-profit is working with multiple pharma and biopharma sponsors and other key collaborators to operationalize a study. The trial will provide principal investigators and their patients consolidated access to test novel therapies matched to specific molecular aberrations in AML.
 
In the trial, newly diagnosed AML patients will enter this study based on screening for specific molecular mutations known to be drivers of their disease, and will be matched to a specific targeted therapy. The LLS expects the scope of the multi-year trial to include 15 to 20 clinical research sites, as many as 10 different treatment arms and 500 patients.
 
INC Research will provide a full range of CRO services ranging from study start-up to project management and clinical operations to biostatistics and medical writing.
 
“The Beat AML Master Trial is a significant milestone for LLS, specifically its commitment to helping AML patients, for whom there has not been an advance in standard treatment in more than 40 years,” said Louis J. DeGennaro, Ph.D., LLS president and chief executive officer. “Working with INC Research will allow us to tap into the company’s long-established relationships with physicians and medical centers to ensure timely delivery of data, a crucial element of this precision medicine approach.”  
 
Nicholas Kenny, Ph.D., executive vice president and general manager for Oncology at INC Research said, “INC’s Oncology team is thrilled to be engaged with LLS in this groundbreaking study. We anticipate this will be a landmark trial for AML patients. We applaud LLS for taking such a progressive approach to find solutions for this lethal blood cancer.  Our shared hope is that AML, like CLL and CML, will yield clinical progress in the face of our advanced knowledge of the disease and the associated targeted therapies.”