122
Participants
Start Date
July 7, 2021
Primary Completion Date
March 21, 2025
Study Completion Date
February 9, 2026
Calaspargase pegol (S95015)
"Part 1: S95015 will be administered at dose of 2000 U/m2, 1500 U/m2 or 1000 U/m2 (dose level based on age and BMI) via a 2-hour intravenous infusion at Day 4 (or 5, or 6) of the induction phase, Days 15 and 43 of the consolidation phase, Day 22 of the interim maintenance phase and Days 4 (or 5, or 6) and 43 of the delayed intensification phase. S95015 starting doses for age and BMI groups will be confirmed.~Patients will receive premedication prior to calaspargase pegol administration (acetaminophen, histamine-1 blocker, and corticosteroids to prevent hypersensitivity reaction) and other backbone chemotherapy agents based on the CALGB 10403 protocol treatment regimen.~Part 2: Patients aged 22 to 39 years + BMI ≤ 35 kg/m2 will be treated with S95015 1750 U/m2.~Patients aged 40 to \< 55 years + BMI ≤ 35 kg/m2 will be treated with S95015 1500 U/m2, unchanged from Part 1. Patients 55 years or older or those with a BMI greater than 35 kg/m2 will no longer be enrolled into Part 2."
NYU Langone/Laura and Isaac Perlmutter Cancer Center, New York
Memorial Sloan Kettering Cancer Center, New York
Northwell Health Cancer Institute, Lake Success
Jefferson Health, Philadelphia
University of Maryland Greenbaum Cancer Center, Baltimore
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
West Virginia University Cancer Institute, Morgantown
University of Miami Health System - Sylvester Comprehensive Cancer Center, Miami
Baptist Clinical Research Institute, Memphis
Cleveland Clinic, Cleveland
University of Chicago Medicine, Chicago
University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion, Westwood
Intermountain Healthcare (IHC), Salt Lake City
Univeristy of California, Los Angeles
City of Hope Comprehensive Cancer Center, Duarte
University of California Irvine Health (UCI Health), Orange
Oregon Health & Science University (OHSU), Portland
University of Washington/Seattle Cancer Care Alliance/Fred Hutch, Seattle
Dana Farber Cancer Institute, Weymouth
ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER