INC Research participating in 'umbrella trial' to accelerate precision therapies
The Beat AML Master Trial was recently launched by the Leukemia & Lymphoma Society’s (LLS) to treat acute myeloid leukemia (AML).
“This is a remarkable, landmark, trial embodying coordination between LLS and multiple pharma companies and support services, consultation with FDA, and direct engagement/collaboration with leading AML physicians to ensure that BeatAML is set up correctly to address a significant disease with a current dismal prognosis,” Nicholas Kenny, PhD, Executive Vice President, Oncology & Hematology, INC Research, told us.
The novel “umbrella trial” design allows all newly diagnosed AML patients at participating sites to be screened for specified molecular aberrations.
“Then, under the umbrella of a single master protocol, they can be assigned to the specific targeted therapy for which they are marker-positive,” added Kenny.
According to Kenny, such trials are considered to be patient- and investigator-centric, as they allow specific selection options under one administrative structure.
“In many ways, this trial/design type seeks to ‘find the trial for the patient’ rather than the traditional ‘find patients for a trial,’” he added.
The trial is also design to speed up the process of finding better treatments for AML.
As Kenny explained, a typical clinical trial only studies one drug or one combination of drugs. However, BeatAML will begin with four different treatments, each being tested in one of several arms of the trial based on a particular genetic mutation. The trial will eventually expand to up to 10 arms, a representative from LLS told us.
“Umbrella studies are designed to test the impact of different drugs on different mutations in a single cancer type,” they added.
Additionally, the trial has one master protocol, which LLS said allows for investigational drugs to be quickly moved into the trial for testing and those that aren’t working to be quickly be moved out of the trial.
The LLS spokesperson added that it will be making treatment decisions within seven days based on the outcome of the genomic analysis.
“By testing multiple drugs simultaneously we have a better chance of advancing therapies show promise in improving outcomes for patients more quickly,” they said.
As part of its involvement, INC will provide overall project management, clinical monitoring, and biometrics support to the trial. “The remit is to be a flexible partner with LLS as this trial matures,” said Kenny.
The trial is set up and the first site is initiating patient enrollment with the first two drugs under the umbrella design.
Additional drugs and study sites will be added incrementally between now and mid-2017, and further investigator and organizational meetings are planned for ASH in December 2016.
