Title: Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents
Principal Investigator: Lewis B. Silverman, MD, Dana-Farber Cancer Institute
Description: Researchers are studying the use of a new set of risk factors to guide treatment decisions for children and adolescents with acute lymphoblastic leukemia (ALL). The goal of this randomized, phase 3 trial is to identify patients who might benefit from stronger treatment and patients who have a high chance of being cured with standard treatment.
The researchers will also evaluate the dosing of pegaspargase, comparing the standard dose (2500 IU/m2 every 2 weeks) with pharmacokinetic-adjusted dosing (starting dose: 2000 IU/m2). The goal is to determine if pharmacokinetic-adjusted dosing will decrease side effects without compromising efficacy.
The primary outcome measures of this study are complete remission rate and event-free survival. Secondary outcomes include overall survival, disease-free survival, nadir serum asparaginase activity, and non-allergic asparaginase activity.
To be eligible for this study, patients must have a confirmed diagnosis of ALL. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by Dana-Farber Cancer Institute in collaboration with Servier.
Clinicaltrial.gov. Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents. NCT03020030. Accessed August 18, 2021.