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Brief Title: Calaspargase Pegol in Adults With ALL
Official Title: A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years With Newly-diagnosed Philadelphia-negative ALL.
Study ID: NCT04817761
Brief Summary: The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.
Detailed Description: The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed in Part 1.
Minimum Age: 22 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
HonorHealth Cancer Transplant Institute, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Univeristy of California, Los Angeles, California, United States
University of California Irvine Health (UCI Health), Orange, California, United States
University of Miami Health System - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
University of Chicago Medicine, Chicago, Illinois, United States
University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion, Westwood, Kansas, United States
University of Maryland Greenbaum Cancer Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Weymouth, Massachusetts, United States
NYU Langone/Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Baptist Clinical Research Institute, Memphis, Tennessee, United States
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Daniel J. DeAngelo, MD, PhD
Affiliation: Dana-Farber Cancer Institute, Boston, MA
Role: PRINCIPAL_INVESTIGATOR