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    The EU Clinical Trials Register currently displays   43202   clinical trials with a EudraCT protocol, of which   7150   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-012437-30
    Sponsor's Protocol Code Number:BUS‐2009/01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-04-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2009-012437-30
    A.3Full title of the trial
    Clofarabine based remission induction followed by haploidentical stem cell
    transplantation in children with refractory hematological malignancies
    A.4.1Sponsor's protocol code numberBUS‐2009/01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSkånes University 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Evoltra
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameClofarabine
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNETOPOSIDE PHOSPHATE
    D.3.9.1CAS number 117091642
    D.3.9.2Current sponsor codeEtoposid
    D.3.9.3Other descriptive nameEtopofos
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50180
    D.3.9.2Current sponsor codeCyclophosphamide
    D.3.9.3Other descriptive nameSendoxan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 2000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMELPHALAN
    D.3.9.1CAS number 148-82-3
    D.3.9.2Current sponsor codeMelfalan
    D.3.9.3Other descriptive nameAlkeran
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHIOTEPA
    D.3.9.1CAS number 52244
    D.3.9.2Current sponsor codeTiotepa
    D.3.9.3Other descriptive nameThiotepa
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMUROMONAB-CD3
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor codeOKT3
    D.3.9.3Other descriptive nameOrthoclone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeRituximab
    D.3.9.3Other descriptive nameMabthera
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMYCOPHENOLATE MOFETIL
    D.3.9.1CAS number 115007-34-6
    D.3.9.2Current sponsor codeMMF
    D.3.9.3Other descriptive nameCellcept
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE HEMISUCCINATE
    D.3.9.1CAS number 2921575
    D.3.9.2Current sponsor codeSteroid
    D.3.9.3Other descriptive nameSoluMedrol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Therapy resitant leukemia in children and young adults
    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
    1.2 Primary Objectives
    a) To improve event free survival for children with acute leukemia resistant to conventional therapy using “bridge to transplant” approach
    b) To demonstrate graft versus leukemia effect in children with therapy resistant leukemia who underwent haploidentical stem cell transplantation with subsequent cell therapy (DLI)
    E.2.2Secondary objectives of the trial
    1.3 Secondary Objectives
    a) Evaluation of induction efficacy measured by response rate and the number of children proceeding to transplant
    b) Tolerance, safety and quality of life
    c) To evaluate hematological and immunological recovery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    3.1 Inclusion Criteria
    I. Target population
    1. Refractory acute lymphoblastic leukemia
    a. Chemoresistant isolated or combined bone marrow relapse
    • Relapse after during/after conventional treatment
    • Relapse >6 months after allogeneic stem cell transplantation
    b. Primary induction failure
    c. Isolated extramedullary relapse after previous HSCT (>6
    months)
    2. Refractory acute myeloblastic leukemia including sAML
    a. Chemoresistant relapse
    • Relapse after during/after conventional treatment
    • Relapse >6 months after allogeneic stem cell
    transplantation[1]
    b. Primary induction failure
    II. Inclusion criteria to start induction treatment with multidrug regimen
    1. Age > 1 and ≤21 years
    2. Patients with previous HCST ≥ 6 m[1]
    3. Provide signed written informed consent patients’, and patients’
    parents/guardians
    a. Older children should be capable of understanding the
    investigational nature, potential risks and benefits of the study,
    and able to provide valid informed consent as well.
    4. Cardiac output SF ≥25%
    5. Have adequate renal and hepatic functions as indicated by the
    following laboratory values:
    • Calculated creatinine clearance ≥90 ml/min/1.73 m2 as
    calculated by the Schwartz formula for estimated glomerular
    filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height
    (cm)/serum creatinine (mg/dl). k is a proportionality constant
    which varies with age and is a function of urinary creatinine
    excretion per unit of body size; 0.45 up to 12 months of age;
    0.55 children and adolescent girls; and 0.70 adolescent boys.
    • Serum bilirubin ≤1.5 × upper limit of normal (ULN)
    • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 × ULN
    • Alkaline phosphatase ≤ 2.5 × ULN
    6. Performance score of ≥70% (Lansky or Karnofsky)
    7. A suitable haploidentical family member available for stem cell
    donation, > 18 years of age, fulfilling institutional criteria for blood
    and marrow donation.
    8. Male and female patients must use an effective contraceptive
    method during the study and for a minimum of 6 months after study
    treatment.
    III. Inclusion criteria to proceed to transplant after induction
    1. Cardiac output SF ≥25%
    2. Have adequate renal and hepatic functions as indicated by the
    following laboratory values:
    • Calculated creatinine clearance ≥90 ml/min/1.73 m2 as
    calculated by the Schwartz formula for estimated glomerular
    filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height
    (cm)/serum creatinine (mg/dl).
    k is a proportionality constant which varies with age and is a
    function of urinary creatinine excretion per unit of body size;
    0.45 up to 12 months of age; 0.55 children and adolescent girls;
    and 0.70 adolescent boys.
    • Serum bilirubin ≤1.5 × upper limit of normal (ULN)
    • Aspartate transaminase (AST)/alanine transaminase (ALT)
    ≤2.5 × ULN
    • Alkaline phosphatase ≤ 2.5 × ULN
    3. Performance score of ≥70% (Lansky or Karnofsky)
    4. A suitable haploidentical family member available for stem cell
    donation, > 18 years of age, fulfilling institutional criteria for blood
    and marrow donation.
    5. Capable of understanding the investigational nature, potential risks
    and benefits of the study, and able to provide valid informed consent.
    6. Female patients of childbearing potential must have a negative serum
    pregnancy test within 2 weeks prior to enrolment.
    7. Male and female patients must use an effective contraceptive
    method during the study and for a minimum of 6 months after study
    treatment.
    E.4Principal exclusion criteria
    3.2 Exclusion Criteria
    1. Current concomitant chemotherapy, radiation therapy, or
    immunotherapy other than as specified in the protocol.
    2. Use of investigational agents within 30 days or any anticancer
    therapy within 2 weeks before study entry with the exception of
    hydroxyurea.
    The patient must have recovered from all acute toxicities from any
    previous therapy.
    3. Have any other severe concurrent disease, or have a history of
    serious organ dysfunction or disease involving the heart, kidney,
    liver, or other organ system that may place the patient at undue risk
    to undergo treatment.
    4. Patients with a systemic fungal, bacterial, viral, or other infection
    not controlled (defined as exhibiting ongoing signs/symptoms
    related to the infection and without improvement, despite
    appropriate antibiotics or other treatment).
    5. Pregnant or lactating patients.
    6. Any significant concurrent malignant disease, illness, or psychiatric
    disorder that would compromise patient safety or compliance,
    interfere with consent, study participation, follow up, or
    interpretation of study results.
    E.5 End points
    E.5.1Primary end point(s)
    1) The number of patients "bridged to transplant" with CLoEC induction
    2) Overall survival day +100 and day +365 after stem cell transplantation
    3) Event free survival day +100 and +365 after stem cell transplantation
    4) Disease free survival day +100 and day +365 after stem cell transplantation
    5) Incidence of garft versus host disease.
    6) Immunological recovery
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    2 years after stem cell transplantation of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    Routin follow up twice a year at the Department of Pediatric Oncology or in case of patiebts >18 years at the Department of Hematology and/or Late Effects Department.
    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 Decision2010-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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