September 3, 2020, Rye Brook, N.Y. and Raleigh, N.C. - The Leukemia & Lymphoma Society (LLS) and PRA Health Sciences (NASDAQ: PRAH) announced today a partnership to launch a first-of-its-kind 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.”
Accelerating Drug Development for Children with Cancer
In 2017, the U.S. Congress passed The Research to Accelerate Cures and Equity (RACE) for Children Act into law, which went into effect on August 18, 2020.
The law requires pharmaceutical and biotechnology companies testing new molecularly targeted compounds for adult cancers to also evaluate them for children’s cancers. Put simply, the new law now will make it standard practice for drug companies to develop their targeted drugs for children with cancer.
“For too long, too many impediments have kept companies from efficiently testing drugs for children with cancer. Passing the RACE Act was a significant step toward opening the door to precision medicines that could make all the difference for kids,” said Gwen Nichols, M.D., Chief Medical Officer of The Leukemia & Lymphoma Society. “The LLS PedAL trial now will bring the RACE Act into actual practice as the companies will be testing their novel agents in children with acute leukemia in the trial.”
The PedAL trial, which is on target to open by summer 2021, is just one of the focus points in the LLS Children’s Initiative, a multi-year endeavor to help children with cancer through pediatric research grants, educational initiatives, patient and family support services, and advocacy.
With a rich history of breaking down siloes and bringing together leaders to fight blood cancers, LLS built LLS PedAL on the success of their Beat AML master trial for adult patients with AML. LLS and PRA have teamed up with the Children’s Oncology Group and the National Cancer Institute to bring the master trial and sub-trials to more than 200 sites across North America, with plans to expand the trial into Europe and Asia.
“LLS PedAL is an ambitious and complex initiative and we are pleased to have PRA Health Sciences as a partner to help bring this urgently needed master clinical trial for children to fruition,” Nichols said.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in Rye Brook, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m., ET.
The LLS Children’s Initiative: Cures and Care for Children with Cancer
The LLS Children’s Initiative is a $100 million multi-year effort to take on children’s cancer through every facet of LLS’s mission: research, patient education and support and policy and advocacy. The LLS Children’s Initiative includes: more pediatric research grants, a global precision medicine clinical trial, expanded free education and support services for children and families and driving policies and laws that break down barriers to care. To learn more, visit www.lls.org/childrens-initiative.
About PRA Health Sciences
PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East and more than 17,500 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.
Andrea Greif, Vice President, Communications, The Leukemia & Lymphoma Society
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Laurie Hurst, Director, Communications and Public Relations, PRA Health Sciences
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