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)
NCT ID: NCT02257684
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2014-09-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pegcrisantaspase
pegcrisantaspase
Interventions
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pegcrisantaspase
Eligibility Criteria
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Inclusion Criteria
2. Be \> 1 to ≤ 21 years of age at study enrollment
3. Have had a ≥ Grade 2 allergic reaction (Common Terminology Criteria for Adverse Events \[CTCAE\] v4.03) to pegaspargase
4. Have ≥ 1 dose(s) of pegaspargase remaining in his/her treatment plan
5. Have a documented SAA level that is below the limit of quantitation per the analytical method.
6. 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.
7. Subjects must have a performance status corresponding to:
* Karnofsky ≥ 50 (for subjects \> 16 years of age)
* Lansky ≥ 50 (for subjects ≤ 16 years of age)
8. 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.
9. Adequate Liver Function defined as:
Bilirubin levels ≤ 2.5x ULN for age, and Direct (conjugated) Bilirubin \< 0.5 mg/dLSGPT (ALT) ≤ 225 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
10. Subjects who are sexually active must agree to use a medically acceptable method of contraception throughout the entire study period and for 4 weeks after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or the partner include abstinence, birth control pills or patches, diaphragm and spermicide, condom and vaginal spermicide, surgical sterilization, postmenopausal, vasectomy (\>6 months prior to baseline), and progestin implant or injection.
11. Able to understand and to sign a written informed consent. All subjects and/or their parent or a legally authorized representative must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
Exclusion Criteria
2. Are receiving another investigational agent or will receive an investigational agent in subsequent phases of protocol therapy that include asparaginase
3. Have a history of ≥ Grade 3 pancreatitis (CTCAE v4.03)
4. Prior history of a CNS thrombotic event or ≥ Grade 3 (CTCAE v4.03) thrombotic event, excluding catheter-associated clots
5. Prior history of asparaginase-associated ≥ Grade 3 (CTCAE v4.03) hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy
6. Blood triglyceride levels \> 500 mg/dL or \> 5.6 mmol/L
7. Hyperglycemia requiring insulin therapy
8. QTc prolongation ≥ 550 msec
9. Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
10. 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.
1 Year
21 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Roman Skowronski, MD, PhD
Role: STUDY_DIRECTOR
Jazz Pharmaceuticals
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Kaiser Permanente
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Benioff Children's Hospital / UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center Center for Cancer & Blood Disorders
Washington D.C., District of Columbia, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children / Indiana University
Indianapolis, Indiana, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Children's Hospital Main Campus
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
C.S. Mott / University of Michigan
Ann Arbor, Michigan, United States
Wayne State University c/o Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota Medical Center - Fairview
Minneaplois, Minnesota, United States
Children's Hospitals & Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Children's Hospital & Medical Center of Omaha
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center, Levine Cancer Institute, Levine Children's Hospital
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Bi-Lo Charities Children's Cancer Center
Greenville, South Carolina, United States
Vanderbilt University Ingram Cancer Center
Nashville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, United States
Seattle Children's Hospital
Seatlle, Washington, United States
University of Wisconsin / American Family Children's Hospital
Madison, Wisconsin, United States
Children's Hospital of Wisconsin / Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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13-011
Identifier Type: -
Identifier Source: org_study_id
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