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    Summary
    EudraCT Number:2020-004894-29
    Sponsor's Protocol Code Number:CL2-95014-002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-09-17
    Trial results View 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 number2020-004894-29
    A.3Full title of the trial
    A multicentre, Phase II Randomized study, Open-label, with 2-arm Parallel Group, comparing the pharmacokinetics of the Liquid and the Lyophilized Formulations of pegaspargase (S95014) in Treatment of Paediatric Patients with Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing the blood levels of both pegaspargase (S95014) formulations (liquid vs lyophilized) in the Treatment of Paediatric Patients with Acute Lymphoblastic Leukemia (ALL)
    A.4.1Sponsor's protocol code numberCL2-95014-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04954326
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recherches Internationales Servier
    B.1.3.4CountryFrance
    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 supportADIR
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherches Internationales Servier
    B.5.2Functional name of contact pointClinical Studies Department
    B.5.3 Address:
    B.5.3.1Street Address50 rue Carnot
    B.5.3.2Town/ citySURESNES CEDEX
    B.5.3.3Post code92284
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155724366
    B.5.5Fax number+33155725412@fax.servier.com
    B.5.6E-mailclinicaltrials@servier.com
    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 Yes
    D.2.1.1.1Trade name Oncaspar
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameS95014
    D.3.2Product code S95014
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegaspargase
    D.3.9.1CAS number 130167-69-0
    D.3.9.2Current sponsor codeS95014
    D.3.9.4EV Substance CodeSUB03666MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Oncaspar
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameS95014
    D.3.2Product code S95014
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegaspargase
    D.3.9.1CAS number 130167-69-0
    D.3.9.2Current sponsor codeS95014
    D.3.9.4EV Substance CodeSUB03666MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 No
    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
    Newly diagnosed paediatric patients with Acute Lymphoblastic Leukemia
    E.1.1.1Medical condition in easily understood language
    Acute Lymphoblastic Leukemia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single intravenous (IV) dose in newly diagnosed paediatric patients with ALL
    E.2.2Secondary objectives of the trial
    To describe the PK of S95014 after administration of either lyophilized or liquid formulation
    To evaluate the achievement of plasma asparaginase activity (PAA) of ≥0.1 U/mL after the administration of either lyophilized or liquid S95014
    To assess the immunogenicity of both lyophilized and liquid S95014 formulations
    To evaluate the safety profile through the occurrence of TEAEs including serious adverse events (SAEs), regardless of causality and severity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 1 to < 18 years
    - Patients with cytologically confirmed and documented newly
    diagnosed ALL according to National Comprehensive Cancer Network
    guidelines2020 (see Appendix 2), excluding B-cell Burkitt ALL
    - Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2(see Appendix 3)
    - Highly effective contraception method
    - Signed informed consent and assent, when appropriate
    E.4Principal exclusion criteria
    - Unlikely to cooperate in the study
    - Pregnant and lactating women
    - Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies
    is allowed
    - Participant already enrolled in the study (informed consent signed)
    - Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period
    - Inadequate hepatic function (bilirubin > 1.5 times upper limit of normal(ULN), transaminases > 5x ULN)
    - Inadequate renal function defined as serum creatinine > 1.5 x ULN
    - Prior treatment with chemotherapy or radiotherapy (except steroids andintrathecal therapy)
    - Prior surgery or bone marrow transplant related to the studied disease
    - Down Syndrome
    - Psychiatric illness/social situation that would limit compliance with study requirements
    - Known history of pancreatitis
    - Known history of significant liver disease
    - Known carriers of HIV antibodies
    - Significant laboratory abnormality likely to jeopardize the patients' safety orto interfere with the conduct of the study, in the investigator's opinion
    - Pre-existing known coagulopathy (e.g. haemophilia and known protein S deficiency)
    - History of previous or concurrent malignancy
    - History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
    - Severe or uncontrolled active acute or chronic infection
    - Uncontrolled intercurrent illness including life-threatening acute tumor lysissyndrome (e.g. with renal failure), symptomatic congestive heart failure,cardiac arrhythmia
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics measurment :
    - Area Under the Concentration-Time Curve (AUC)
    - Maximum observed plasma asparaginase activity (Cmax)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 3 pre-dose just after the infusion,4h after the end of infusion; Day 4: 24h after the end of infusion;Day 5: 48h after the end of infusion; Day 8, Day 10, Day 12, Day 17, Day 21, Day 28
    E.5.2Secondary end point(s)
    Pharmacokinetics measurements : additional PK parameters from the ones defined as primary endoint
    Activity measurements : Plasma Asparaginase Activity (PAA) of ≥ 0.1 U/mL after the administration of either liquid or lyophilized S95014
    Imunogenicity measurements : Anti S95014 and anti-PEG antibodies will be assessed for both lyophilized and liquid S95014 formulations
    Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Advers Event (SAEs) causality and severity based on NCI CTCAE 5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetics measurements : 14 days post-dose
    Activity measurements : Day 10, Day 17, Day 21 and Day 28 of induction
    Imunogenicity measeurements: Day 3 pre-dose, Day 17 and Day 28
    Incidence of TAEs and SAEs : Through study completion
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pharmacokinetics comparability
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    Russian Federation
    E.8.7Trial has a data monitoring committee No
    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
    End of trial is defined as the date of the last visit of the last participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 88
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 44
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 44
    F.1.2Adults (18-64 years) No
    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 No
    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 88
    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)
    After discontinuation of the study, the participants' treatment is left to the physician's discretion, according to local regulation and practice. Provided that the inclusion/non inclusion criteria are fulfilled, the participant will be proposed to enter a roll-over study (CL2-95014-003) using lyophilized S95014 during the consolidation phase, in compliance with ALL-MB 2015 protocol.
    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: Russian Federation
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