Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label Erwinaze | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asparaginase Erwinia chrysanthemi | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two Day Nadir Serum Asparaginase Activity (NSAA) Level | To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | 48 hours post-dose 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours | To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | 48 hours post-dose 5 |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lynda Vrooman, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital of Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26376459 | Derived | Vrooman LM, Kirov II, Dreyer ZE, Kelly M, Hijiya N, Brown P, Drachtman RA, Messinger YH, Ritchey AK, Hale GA, Maloney K, Lu Y, Plourde PV, Silverman LB. Activity and Toxicity of Intravenous Erwinia Asparaginase Following Allergy to E. coli-Derived Asparaginase in Children and Adolescents With Acute Lymphoblastic Leukemia. Pediatr Blood Cancer. 2016 Feb;63(2):228-33. doi: 10.1002/pbc.25757. Epub 2015 Sep 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Safety Population | All participants who received at least 1 dose of Erwinaze |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Three Day NSAA Level | To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | 72 hours post-dose 6 |
| Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours | To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | 72 hours post-dose 6 |
| Nadir Serum Asparaginase Activity Over Time | To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks). | 4 weeks to 30 weeks |
| Orange County |
| California |
| 92868 |
| United States |
| Stanford Medical Center | Palo Alto | California | 94304 | United States |
| Children's Hospital | Aurora | Colorado | 80045 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60611 | United States |
| John Hopkins | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Minnesota | Minneapolis | Michigan | 55455 | United States |
| Children's Hospital and Clinics of Minnesota | Minneapolis | Minnesota | 55406 | United States |
| UMDNJ/Robert Wood Johnson | New Brunswick | New Jersey | 08903 | United States |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| Montifiore Medical Center | The Bronx | New York | 10467 | United States |
| Oregon Health & Sciences | Portland | Oregon | 97239 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Inova Fairfax Medical Center | Falls Church | Virginia | 22042 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| McMasters University Medical Center | Hamilton | Ontario | L8S4R1 | Canada |
| Sick Children's Hospital | Toronto | Ontario | m561X8 | Canada |
| Hospital St. Justine | Saint Catherine | Quebec | H3T1CS | Canada |
| Quebec Children's Hospital | Sainte-Foy | Quebec | CIV462 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All patients who received at least one dose of Erwinaze |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Two Day Nadir Serum Asparaginase Activity (NSAA) Level | To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | The Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of Erwinaze and were considered evaluable. | Posted | Mean | Standard Deviation | (IU/mL) | 48 hours post-dose 5 |
|
|
| |||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours | To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are > or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | Posted | Count of Participants | Participants | 48 hours post-dose 5 |
|
| ||||||||||||||||||||||||||||
| Secondary | Three Day NSAA Level | To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | Posted | Mean | Standard Deviation | (IU/mL) | 72 hours post-dose 6 |
|
| |||||||||||||||||||||||||||
| Secondary | Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours | To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are > or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose. | Posted | Count of Participants | Participants | 72 hours post-dose 6 |
|
| ||||||||||||||||||||||||||||
| Secondary | Nadir Serum Asparaginase Activity Over Time | To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks). | This population consisted of participants who completed Course 4 with Pharmacokinetic(s) (PK) assessments 48 hours after dose 5 (week 8). | Posted | Mean | Standard Deviation | IU/mL | 4 weeks to 30 weeks |
|
|
4 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | All participants who received at least 1 dose of Erwinaze | 0 | 30 | 15 | 30 | 23 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sinus Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Posterior Reversible Encephalopathy Syndrome | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Disclosure & Transparency | Jazz Pharmaceuticals | 2158709177 | ClinicalTrialDisclosure@JazzPharma.com |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718243 | asparaginase erwinia chrysanthemi recombinant |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|