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    Summary
    EudraCT Number:2016-003409-33
    Sponsor's Protocol Code Number:AllopurinolALL2.0
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-16
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2016-003409-33
    A.3Full title of the trial
    Optimizing 6-mercaptopurine therapy in paediatric acute lymphoblastic leukemia by using allopurinol
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in children 1-19 years on maintenance therapy for acute lymphoblastic leukemia
    A.3.2Name or abbreviated title of the trial where available
    Allopurinol in maintenance
    A.4.1Sponsor's protocol code numberAllopurinolALL2.0
    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 SponsorQueen Silvias Childrens and Adolescents Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportQueen Silvias Childrens and Adolescents Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueen Silvias Childrens and Adolescents Hospital
    B.5.2Functional name of contact pointJonas Abrahamsson
    B.5.3 Address:
    B.5.3.1Street AddressRondvägen 10
    B.5.3.2Town/ cityGothenburg
    B.5.3.4CountrySweden
    B.5.4Telephone number+4631215486
    B.5.6E-mailvobjab@gmail.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 Allonol, Apurin Sandoz, Zyloric
    D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm Oy, Sandoz/Novartis Finland Oy, Navamedic AB
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameAllopurinol
    D.3.2Product code Allopurinol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameALLOPURINOL
    D.3.9.4EV Substance CodeSUB05338MIG
    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) No
    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
    Pediatric acute lymphoblastic leukemia
    E.1.1.1Medical condition in easily understood language
    Pediatric acute lymphoblastic leukemia, hematologic malignancy
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to investigate if addition of allopurinol during maintenance therapy for acute lymphoblastic leukemia gives the same effects as in inflammatory bowel disease, i.e. higher 6-tioguaninen (6TG), lower 6-methylmercaptopurine and reduced hepatotoxicity. More specifically we will investigate if allopurinol increases the proportion of patients with 6TG levels above 200 nail/mmol Hb and reduces the proportion with 6MMP levels in excess of 15000 nail/mmol Hb.
    E.2.2Secondary objectives of the trial
    Secondary aims are to document how allopurinol affects laboratory parameters for hepatotoxicity and metabolic function after fasting.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All children with standard or intermediate risk acute lymphoblastic leukemia, aged 0-18 years at time of diagnosis of leukemia and treated according to ALL2008 protocols and with TPMT wild type who start maintenance 2 phase are eligible.
    E.4Principal exclusion criteria
    -Mature B celL lymphoblastic leukemia; t(9;22) positive acute lymphoblastic leukemia
    -Unknown TPMT status or presence of TPMT mutation (both heterozygous and homozygous)
    -Known intolerance to any of the chemotherapeutic drugs in the protocol
    -Major organ failure precluding administration of planned chemotherapy
    -Sever liver toxicity defined as persistent (≥ two weeks) elevation of either S-bilirubin > 50 ��mol/l or S-GPT > 20 x UNL (upper normal limit) or P-Protrombin complex > 1.5
    -Reduced kidney function defined as S creatine ≥ 2 x UNL
    -Lactating female or female of childbearing potential not using adequate contraception
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the fraction of patients with &TG levels above 200 nmol/mmol Hb after 12 weeks of allopurinol treatment (week 25) vs. after 12 weeks of standard maintenance therapy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 13 and 25
    E.5.2Secondary end point(s)
    Secondary endpoints are to compare the following parameters with or without allopurinol treatment:
    -tThe mean level of 6TG and DNA-TGN at week 13 and 25
    -The mean level of 6MMP at week 13 and 25
    -The weighted mean level of Hb, WBC, platelets and ANC during the respective treatment phases
    -Laboratory measures of hepatotoxicity (weighed mean S-Bilirubin and S-GPT) during treatment phases
    -Laboratory measures of hypoglycaemia and metabolic dysfunction (cumulative incidence of hypoglycaemia during the treatment phases)
    -Serious adverse events (cumulative incidence during the treatment phases)
    -The mean cumulative doses of 6MP and Mix days with treatment interruption during the two treatment phases
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 13 and 25
    Treatment phases weeks 1-13 and 13-25
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Addition of allopurinol to maintenance therapy
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 60
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 45
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 the end of the trial, the best treatment plan will be decided by each investigator according to the state of health of the patient concerned.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-07
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