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    Summary
    EudraCT Number:2025-000263-36
    Sponsor's Protocol Code Number:JZP458-201
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-10-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000263-36
    A.3Full title of the trial
    An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. coli-derived Asparaginases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. coli-derived Asparaginases
    A.4.1Sponsor's protocol code numberJZP458-201
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/453/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJazz Pharmaceuticals
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJazz Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJazz Pharmaceuticals
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address2005 Market Street
    B.5.3.2Town/ cityPhiladelphia
    B.5.3.3Post codePA 19103
    B.5.3.4CountryUnited States
    B.5.4Telephone number012158323750
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code JZP458
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcrisantaspase
    D.3.9.2Current sponsor codeJZP458
    D.3.9.3Other descriptive nameRECOMBINANT L-ASPARAGINASE
    D.3.9.4EV Substance CodeSUB130490
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL)
    E.1.1.1Medical condition in easily understood language
    Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - 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
    E.2.2Secondary objectives of the trial
    - 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(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.
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 197
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 54
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 31
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 228
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Each patient will be followed for at least 30 days following their last dose of the last course of RC-P.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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