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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02257684
Other study ID # 13-011
Secondary ID
Status Terminated
Phase Phase 2
First received September 22, 2014
Last updated January 6, 2016
Start date September 2014
Est. completion date September 2016

Study information

Verified date February 2015
Source Jazz Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 21 Years
Eligibility Inclusion Criteria:

1. Have a diagnosis of ALL/LBL

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:

1. Have previously received Erwinia asparaginase

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
pegcrisantaspase


Locations

Country Name City State
United States C.S. Mott / University of Michigan Ann Arbor Michigan
United States Children's Hospital Colorado Aurora Colorado
United States Dell Children's Medical Center Austin Texas
United States Johns Hopkins University Baltimore Maryland
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 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Medical Cincinnati Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States The University of Texas Southwestern Medical Center Dallas Texas
United States Wayne State University c/o Children's Hospital of Michigan Detroit Michigan
United States Bi-Lo Charities Children's Cancer Center Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Penn State Children's Hospital Hershey Pennsylvania
United States Texas Children's Hospital / Baylor College of Medicine Houston Texas
United States Riley Hospital for Children / Indiana University Indianapolis Indiana
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic Jacksonville Florida
United States Children's Mercy Hospital - Kansas City Kansas City Missouri
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 Kosair Children's Hospital Louisville Kentucky
United States Children's Hospital Central California Madera California
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 University of Minnesota Medical Center - Fairview Minneaplois Minnesota
United States Children's Hospitals & Clinics of Minnesota Minneapolis Minnesota
United States Vanderbilt University Ingram Cancer Center Nashville Tennessee
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 Children's Hospital Main Campus New Orleans Louisiana
United States Kaiser Permanente Oakland California
United States The University of Oklahoma Health Sciences Center Oklahoma Oklahoma
United States Children's Hospital & Medical Center of Omaha Omaha Nebraska
United States Children's Hospital of Orange County Orange California
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States UCSF Benioff Children's Hospital / UCSF Benioff Children's Hospital San Francisco California
United States Seattle Children's Hospital Seatlle Washington
United States Washington University School of Medicine St. Louis Missouri
United States All Children's Hospital St. Petersburg Florida
United States Children's National Medical Center Center for Cancer & Blood Disorders Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 14 days No
Primary The serum asparaginase activity 14 days after the first infusion of study drug and the adverse events in all participants. 1 Year Yes
Secondary 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 No
Secondary The SAA levels over time following repeated administration in children and young adults ALL/LBL and hypersensitivity to pegaspargase 30 Days No
Secondary The immunogenicity of IV pegcristaspase by testing anti-pegcrisantaspase and anti-PEG binding and neutralizing antibodies 30 Days Yes
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