Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL)
Conditions
Interventions
Product Code: JZP458
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: crisantaspase
Current Sponsor code: JZP458
Other descriptive name: RECOMBINANT L-ASPARAGINASE
Concentrati
Sponsors
Jazz Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Able to sign a written informed consent, and/or have a legally authorized representative sign. - Pediatric and adult patients with diagnosis of ALL or LBL. - Have had an allergic reaction to a long-acting E. coli-derived asparaginase or have silent inactivation. - Have 1 or more courses of E. coli derived asparaginase remaining in his/her treatment plan. - Have fully recovered from prior allergic reaction to E. coli-derived asparaginase. - Have adequate liver function. - Female patients of childbearing potential and male patients who have female partners of childbearing potential agree to use medically acceptable methods of contraception. Are the trial subjects under 18? yes Number of subjects for this age range: 197 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Have previously received asparaginase Erwinia chrysanthemi or RC-P - Have relapsed ALL or LBL - Are treated with another investigational agent and/or device - Have history of = Grade 3 pancreatitis - Prior history of asparaginase-associated = Grade 3 hemorrhagic event or asparaginase-associated thrombus - Patients who in the opinion of the Investigator may not be able to comply with the efficacy and safety monitoring requirements of the study - Patients who have any serious active disease or co-morbid medical condition or psychiatric illness that would prevent the patient from signing the informed consent or would prevent the patient from completing one course of RC-P. - Pregnant or lactating females or females of childbearing potential not willing to use birth control or stop breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine the efficacy of intramuscular (IM) RC-P administration as measured by the response in Cohort 1 and Cohort 2, defined as the last 72-hour nadir serum asparaginase activity (NSAA) level = 0.1 IU/mL during the first course - To assess the safety and tolerability of IM RC-P in patients with ALL/LBL who are hypersensitive to E. coli-derived asparaginases;Secondary Objective: - To determine the efficacy of IM RC-P administration as measured by the response in Cohort 1 and Cohort 2, defined as the last 48-hour NSAA level = 0.1 IU/mL during the first course - To determine the efficacy of IM RC-P administration as measured by the response in Cohort 1 and Cohort 2, defined as the last 48-hour and the last 72-hour NSAA levels = 0.4 IU/mL during the first course - To characterize the pharmacokinetics (PK) of IM RC-P using a population PK approach, and to explore exposure-response correlations - To assess the immunogenicity of IM RC-P following repeat administration of RC-P;Primary end point(s): - The primary efficacy endpoint of the study is the response rate, defined as the proportion of patients with the last 72-hour NSAA level = 0.1 IU/mL during the first course of IM RC-P. - The primary safety endpoint of the study is the safety and tolerability of IM RC-P in patients with ALL/LBL who are hypersensitive to E. coli-derived asparaginases. ;Timepoint(s) of evaluation of this end point: - Blood samples were collected for serum asparaginase activity level determination (Baseline up to 2 weeks). - Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients with the last 48-hour NSAA level = 0.1 IU/mL during the first course of IM administration of RC-P. - Proportion of patients with the last 48-hour NSAA level = 0.4 IU/mL during the first course of IM administration of RC-P - Proportion of patients with the last 72-hour NSAA level = 0.4 IU/mL during the first course of IM administration of RC-P - Characterization of the PK of IM RC-P based on SAA using a population PK approach and exposure-response correlations - Incidence of anti-drug antibody formation against RC-P;Timepoint(s) of evaluation of this end point: - Baseline up to 2 weeks - Baseline up to 2 weeks - Baseline up to 2 weeks - Up to 2 weeks | — |
Countries
Canada, United States
Contacts
Public ContactClinical Trial Disclosure
Jazz Pharmaceuticals
Outcome results
None listed