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Completed Phase 2Phase 3 Interventional Results available

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

ClinicalTrials.gov ID: NCT04145531

Public ClinicalTrials.gov record NCT04145531. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Multicenter Study of Recombinant Crisantaspase Produced in Pseudomonas Fluorescens (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. Coli-derived Asparaginases

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.

Study identification

NCT ID
NCT04145531
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
229 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 27, 2019 (Actual)
Primary completion
Jul 13, 2022 (Actual)
Completion
Jul 13, 2022 (Actual)
Last update posted
Nov 18, 2023

2019 – 2022

United States locations

U.S. sites
67
U.S. states
30
U.S. cities
61
Facility City State ZIP Site status
Children's of Alabama Birmingham Alabama 35233 —
Phoenix Children's Hospital Phoenix Arizona 85016 —
Arkansas Children's Hospital Little Rock Arkansas 72202 —
Kaiser Permanente - Orange County - Anaheim Medical Center Anaheim California 92806 —
Kaiser Permanente - Downey Medical Center Downey California 90242 —
Kaiser Permanente - Fontana Medical Center Fontana California 92335 —
Loma Linda University Medical Center Loma Linda California 92350 —
MemorialCare Miller Children's and Women's Hospital Long Beach Long Beach California 90806 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Kaiser Permanente- Los Angeles Medical Center Los Angeles California 90027 —
Benioff Children's Hospital Oakland Oakland California 94609 —
Kaiser Permanente - Oakland Medical Center Oakland California 94611 —
Children's Hospital of Orange County Main Campus - Orange Orange California 92868 —
Kaiser Permanente - Roseville Medical Center Roseville California 95661 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
Kaiser Permanente - San Diego Medical Center San Diego California 92120 —
University of California San Francisco Benioff Children's Hospital - Mission Bay San Francisco California 94158 —
Kaiser Permanente - Santa Clara Medical Center Santa Clara California 95051 —
Connecticut Children's Medical Center Hartford Connecticut 06106 —
Smilow Cancer Hospital - New Haven New Haven Connecticut 06511 —
Nemours Alfred I. Dupont Hospital for Children Wilmington Delaware 19803 —
Children's National Health System Washington D.C. District of Columbia 20010 —
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 —
Memorial Medical Office Centre Hollywood Florida 33021 —
Nemours Children's Specialty Care Jacksonville Jacksonville Florida 32207 —
AdventHealth Orlando Orlando Florida 32803 —
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 —
Scottish Rite Hospital Atlanta Georgia 30342 —
Kapi'olani Medical Center for Women and Children Honolulu Hawaii 96826 —
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Norton Children's Hospital Louisville Kentucky 40202 —
Dana-Farber/Boston Children's Cancer and Blood Disorders Center Boston Massachusetts 02215 —
C.S. Mott Children's Hospital Ann Arbor Michigan 48109 —
Children's Minnesota Minneapolis Minnesota 55404 —
Masonic Cancer Center Minneapolis Minnesota 55455 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Washington University School of Medicine in Saint Louis St Louis Missouri 63110 —
Alliance for Childhood Diseases Las Vegas Nevada 89135 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Morristown Medical Center Morristown New Jersey 07960 —
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903 —
Cohen Children's Medical Center New Hyde Park New York 11040 —
NYU - Stephen D. Hassenfeld Children's Center for Cancer and Blood Disorders New York New York 10016 —
Herbert Irving Comprehensive Cancer Center New York New York 10032 —
Memorial Sloan-Kettering Cancer Center - New York New York New York 10065 —
Wake Forest Baptist Health Winston-Salem North Carolina 27157 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Nationwide Children's Hospital Columbus Ohio 43205 —
The Children's Hospital at Oklahoma University Medical Center Oklahoma City Oklahoma 73104 —
Oregon Health and Science University Portland Oregon 97201 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224 —
Neurology Clinic, P.C Cordova Tennessee 38018 —
East Tennessee Children's Hospital Knoxville Tennessee 37913 —
St. Jude Children's Research Hospital Memphis Tennessee 38105 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Children's Blood and Cancer Center Austin Texas 78723 —
Medical City Dallas Hospital Dallas Texas 75230 —
University of Texas Southwestern Medical Center Dallas Texas 75390 —
Texas Children's Hospital Houston Texas 77030 —
Methodist Hospital - San Antonio San Antonio Texas 78229 —
Primary Children's Hospital Salt Lake City Utah 84113 —
Inova Medical Group - Fairfax Hospital Falls Church Virginia 22042 —
Children's Hospital of The King's Daughters Norfolk Virginia 23507 —
Massey Cancer Center Richmond Virginia 23220 —
Seattle Children's Hospital Seattle Washington 98105 —
Providence Sacred Heart Medical Center Spokane Washington 99204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04145531, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 18, 2023 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04145531 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →