RYE BROOK, N.Y. and
RALEIGH, N.C., Sept. 3, 2020 /PRNewswire/ -- 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's Role
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.
MEDIA INQUIRIES:
Andrea Greif, Vice President,
Communications, The Leukemia & Lymphoma Society
andrea.greif@lls.org | (914) 772-3027
Laurie Hurst, Director,
Communications and Public Relations, PRA Health Sciences
hurstlaurie@prahs.com | +1 (919) 786-8435
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SOURCE The Leukemia & Lymphoma Society (LLS)