PRA Health Sciences, LLS Collaborate on Global Trial for Children with Acute Leukemia

The Leukemia & Lymphoma Society (LLS) and PRA Health Sciences has announced a partnership to launch a global master clinical trial to develop new treatments for children with relapsed acute leukemia.

The new LLS PedAL (Pediatric Acute Leukemia) master clinical trial will test, simultaneously, multiple targeted therapies for children who experience a relapse of their acute leukemia, (approximately 40% of children with acute myeloid leukemia (AML) and 20% of children with high-risk acute lymphoblastic leukemia (ALL) will, unfortunately, relapse). The study will take place at more than 200 sites worldwide that are part of the NCI-supported Children's Oncology Group (COG) network of children's hospitals, including those in the U.S., Australia, New Zealand, and Canada. The LLS PedAL team will also collaborate with other overseas partners in the UK and EU to implement the trial in those regions. Through these established clinical trial infrastructures, nearly every child in these regions who experiences a relapse of acute leukemia will have access to the trial.

The LLS PedAL trial will launch with several novel therapies to treat children with relapsed acute leukemia, with plans to add additional treatments as they become available. The study will ensure that every child with relapsed AML and many with ALL will be screened to identify their disease subtype and matched to the most appropriate targeted treatment. Some of these patients will participate in LLS PedAL substudies, while others will be referred to other treatments, including other open clinical trials, based on discussions with their physicians.

PRA will serve as the contract research organization for LLS PedAL, managing many aspects of the trial, from coordinating with all of the study sites, ensuring that the study protocols are executed properly, to monitoring the data quality and safety reporting. PRA will also provide guidance for submissions to the U.S. Food Drug Administration and international regulatory agencies. PRA will implement state of the art technology solutions that will allow the trial to be digitally-enabled to best fit the patients' lifestyles, minimize the burden of participation, and keep the trial current throughout the lifecycle.

"PRA is proud to be the partner of LLS and its strong network of sites for the LLS PedAL trial," said Dr. Mark Sorrentino, Vice President, Center for Pediatric Clinical Development at PRA Health Sciences. "Patients and their parents are our focus, and they depend on clinical research as a care option, especially in the rarest of cases. We can leverage our strong pediatric and hematology/oncology expertise globally to help accelerate treatments to these kids and assist their families during a critical time."