Study Stopped
Sponsor decision
A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)
1 other identifier
interventional
4
1 country
43
Brief Summary
The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedApril 4, 2017
March 1, 2017
5 months
September 22, 2014
January 5, 2017
March 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1
15 days during Course 1
The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.
1 Year
Secondary Outcomes (3)
The Pharmakokinetic (PK) Profile of IV Pegcrisantaspase in Children and Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase. Pharmakokinetic Profiles to be Assessed Are: Half Life, Elimination Rate, Tmax, Cmax, AUC.
14 Days
The SAA Levels Over Time Following Repeated Administration in Children and Young Adults ALL/LBL and Hypersensitivity to Pegaspargase
30 Days
The Immunogenicity of IV Pegcristaspase by Testing Anti-pegcrisantaspase and Anti-PEG Binding and Neutralizing Antibodies
30 Days
Study Arms (1)
Pegcrisantaspase
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have a diagnosis of ALL/LBL
- Be \> 1 to ≤ 21 years of age at study enrollment
- Have had a ≥ Grade 2 allergic reaction (Common Terminology Criteria for Adverse Events \[CTCAE\] v4.03) to pegaspargase
- Have ≥ 1 dose(s) of pegaspargase remaining in his/her treatment plan
- Have a documented SAA level that is below the limit of quantitation per the analytical method.
- Subjects must have, in the opinion of the investigator, fully recovered from prior allergic reaction to pegaspargase. Subjects must have completed antihistamine, epinephrine, and/or corticosteroid treatment for the allergic reaction ≥ 24 hours prior to pegcrisantaspase administration.
- Subjects must have a performance status corresponding to:
- Karnofsky ≥ 50 (for subjects \> 16 years of age)
- Lansky ≥ 50 (for subjects ≤ 16 years of age)
- Adequate Renal Function Defined as:
- Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 or
- A serum creatinine based on age/gender as follows:
- Age Maximum Serum Creatinine (mg/dL) Male Female 1 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
- ≥ 16 years 1.7 1.4
- The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz \& Gauthier 1985) utilizing child length and stature data published by the CDC.
- +4 more criteria
You may not qualify if:
- Have previously received Erwinia asparaginase
- Are receiving another investigational agent or will receive an investigational agent in subsequent phases of protocol therapy that include asparaginase
- Have a history of ≥ Grade 3 pancreatitis (CTCAE v4.03)
- Prior history of a CNS thrombotic event or ≥ Grade 3 (CTCAE v4.03) thrombotic event, excluding catheter-associated clots
- Prior history of asparaginase-associated ≥ Grade 3 (CTCAE v4.03) hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy
- Blood triglyceride levels \> 500 mg/dL or \> 5.6 mmol/L
- Hyperglycemia requiring insulin therapy
- QTc prolongation ≥ 550 msec
- Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
- Subjects who have any serious active disease or co-morbid medical condition (according to investigator's decision), or psychiatric illness that would prevent the subject from signing the informed consent form, assent form or informed consent form by parents, pending institutional requirements, or per investigator's opinion, would prevent the subject from completing one course of pegcrisantaspase.
- Pregnant or lactating females or females of childbearing potential not willing to use an adequate method of birth control for the duration of the study. Female subjects who are lactating who do not agree to stop breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Miller Children's Hospital
Long Beach, California, 9080, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027-6016, United States
Children's Hospital Central California
Madera, California, 93636, United States
Kaiser Permanente
Oakland, California, 94611, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
UCSF Benioff Children's Hospital / UCSF Benioff Children's Hospital
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's National Medical Center Center for Cancer & Blood Disorders
Washington D.C., District of Columbia, 20010, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children / Indiana University
Indianapolis, Indiana, 46202, United States
Kosair Children's Hospital
Louisville, Kentucky, 40202, United States
Children's Hospital Main Campus
New Orleans, Louisiana, 70118, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
C.S. Mott / University of Michigan
Ann Arbor, Michigan, 48109-5718, United States
Wayne State University c/o Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Minnesota Medical Center - Fairview
Minneaplois, Minnesota, 55455, United States
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 37212, United States
Children's Hospital & Medical Center of Omaha
Omaha, Nebraska, 68114, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center, Levine Cancer Institute, Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Cincinnati Children's Hospital Medical
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Children's Hospital
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Bi-Lo Charities Children's Cancer Center
Greenville, South Carolina, 29681, United States
Vanderbilt University Ingram Cancer Center
Nashville, Tennessee, 37212, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seatlle, Washington, 98105, United States
University of Wisconsin / American Family Children's Hospital
Madison, Wisconsin, 53792, United States
Children's Hospital of Wisconsin / Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only 1 patient achieved the predefined SAA level above the 0.1 IU/mL therapeutic threshold 14 days following IV pegcrisantaspase dose in Course 1. Therefore, the corresponding PK parameters for repeated administration were not calculated.
Results Point of Contact
- Title
- Head of Clinical Development
- Organization
- Jazz Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Roman Skowronski, MD, PhD
Jazz Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2014
First Posted
October 6, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2015
Study Completion
January 1, 2016
Last Updated
April 4, 2017
Results First Posted
February 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share