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SPARK-ALL: Calaspargase Pegol in Adults With ALL
Sponsor: Institut de Recherches Internationales Servier
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.
Official title: SPARK-ALL: 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.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2021-07-07
Completion Date
2025-04-06
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (21)
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
Northwell Health Cancer Institute
Lake Success, New York, United States
NYU Langone/Laura and Isaac Perlmutter Cancer Center
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
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
Jefferson Health
Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Intermountain Healthcare (IHC)
Salt Lake City, Utah, United States
University of Washington/Seattle Cancer Care Alliance/Fred Hutch
Seattle, Washington, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States