Q&A on the APAL2020D trial
(also known as the PedAL trial)
with Seth Karol, MD, principal investigator for North America
Seth Karol is principal investigator for North America on the APAL2020D trial.
Q. What current treatments are available for children with relapsed AML and how well do they work?
A. Standard chemotherapy approaches include FLA (fludarabine and high-dose cytarabine) with or without GO (gemtuzumab ozogamicine). The effectiveness of this therapy varies based on details of the relapse (first or later relapse, a short or long period of remission before relapse). Unfortunately, survival after relapse is less than 50%.
Q. What makes this trial stand out from other pediatric leukemia trials?
A. This is the first randomized trial in relapsed pediatric AML in more than 20 years. It can change the standard of care for children with this disease. It is also the first randomized trial of venetoclax in children or patients with relapsed AML.
Q. As the trial’s principal investigator for North America, what does your role entail?
A. I helped design the trial and help oversee the trial to ensure it continues to run well.
Q. How has prior research conducted at St. Jude Children’s Research Hospital helped lay the groundwork for the treatment regimen in this trial?
A. The VENAML trial at St. Jude was the first to show that venetoclax could be combined with strong chemotherapy. Findings from the VENAML trial, which were published in Lancet Oncology in 2021, laid the groundwork for the current trial.
Q. How does a collaborative trial of this size improve the study process and expedite findings?
A. A large, randomized trial like this can only be done in collaboration with sites from around the U.S. and the world. This enables us to treat enough patients quickly to ensure that the trial findings are as meaningful as possible.
Q. What ages will be eligible for the trial at St. Jude?
A. From one month old until they reach 22 years old.
Q. How will this trial change the way we treat children with relapsed leukemias?
A. The better treatment arm of this trial will be considered the standard of care going forward for children with relapsed AML.
Q. What other trials are anticipated in the near future that may be able to build on the findings from this one?
A. St. Jude has an upcoming trial called AML23. This trial will test venetoclax in children with newly diagnosed AML.