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    Summary
    EudraCT Number:2007-003798-16
    Sponsor's Protocol Code Number:372-07
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-13
    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
    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 ConcernedIreland - HPRA
    A.2EudraCT number2007-003798-16
    A.3Full title of the trial
    AML 17: Working Parties on Leukaemia in Adults and Children Trial in Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndrome 17
    AML 17: Working Parties on Leukaemia in Adults and Children Trial in Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndrome 17
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AML 17: Working Parties on Leukaemia in Adults and Children Trial in Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndrome 17
    AML 17: Working Parties on Leukaemia in Adults and Children Trial in Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndrome 17
    A.3.2Name or abbreviated title of the trial where available
    AML17
    A.4.1Sponsor's protocol code number372-07
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN55675535
    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 SponsorCardiff University
    B.1.3.4CountryUnited Kingdom
    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 organisationCardiff University, School of Medicine
    B.5.2Functional name of contact pointAlison Jenkins
    B.5.3 Address:
    B.5.3.1Street AddressNeuadd Meironnydd
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCF14 4YS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442920687464
    B.5.6E-mailjenkinsac1@cardiff.ac.uk
    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 Clofarabine (Evoltra)
    D.2.1.1.2Name of the Marketing Authorisation holderBioenvision
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) 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 Yes
    D.3.11.13.1Other medicinal product typenucleoside analogue
    D.IMP: 2
    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.2.1.1.1Trade name Gemtuzumab Ozogamicin (Mylotarg)
    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 nameMylotarg
    D.3.2Product code Gemtuzumab Ozogamicin
    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.3.11 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) 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 Yes
    D.3.11.13.1Other medicinal product typeimmunoconjugate of humanised monoclonal antibody linked to calicheamicin
    D.IMP: 3
    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 Trisenox
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTrisenox
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) 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 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 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 Yes
    D.3.11.13.1Other medicinal product typeArsenic Trioxide
    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 Myeloid Leukaemia and High Risk Myelodysplastic Syndrome
    E.1.1.1Medical condition in easily understood language
    Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    There are two distinct parts to this trial.

    For patients with acute myeloid leukaemia (AML) (other than acute promyelocytic leukaemia) and high risk myelodysplastic syndrome:

    - To compare two induction chemotherapy schedules D(90)A versus D(60)A in course 1, followed by D(50)A as course 2 in both arms.
    - To compare three versus four courses of treatment in total, comparing one versus two courses of HD-Ara-C in consolidation.
    - In high risk patients to compare novel treatment, Daunorubicin/Clofarabine vs standard FLAG-Ida.
    - In high risk patients, evaluate the value of allogeneic stem cell transplantation (SCT), whether standard allogeneic (allo-SCT) or non-myeloablative ―mini‖ allogeneic (mini-SCT).
    - To assess the clinical value of minimal residual disease (MRD) monitoring for patients‘ overall survival.

    For patients with acute promyelocytic leukaemia (APL):

    - To compare the Idarubicin based, AIDA Schedule with the chemo-free combination of ATRA and Arsenic Trioxide.
    E.2.2Secondary objectives of the trial
    Blood and bone marrow will be required at diagnosis, during remission and at relapse to evaluate the therapeutic relevance of morphological, cytogenetic, molecular-genetic and immunophenotypic assessments, with particular respect to:
    - The relevance of the molecular and immunophenotypic detection of minimal residual disease
    - The relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission.
    - To correlate plasma arsenic levels with disease response and treatment-related toxicities including differentiation syndrome in APL patients allocated to receive ATO therapy
    - To store excess diagnostic material for future research.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for Non APL Leukaemia
    Patients:
    - They have one of the forms of acute myeloid leukaemia as defined by the WHO Classification (Appendix A) — this can be any type of de novo or secondary AML or high risk Myelodysplastic Syndrome (defined as >10% bone marrow blasts).
    - Patients with acute promyelocytic leukaemia (APL) are eligible and should be entered into the randomisations specifically for APL (see Section 19).
    - They are considered suitable for intensive chemotherapy.
    - They should normally be under the age of 60, but patients over this age are eligible if intensive therapy is considered a suitable option.
    - Patients must have liver function tests within twice the upper limit of the normal local range to receive Mylotarg in course 2 for the Core Binding Factor Leukaemia subset.
    - Women of child-bearing potential (ie women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence. Intrauterine device (IUD) and must have a negative pregnancy test within 2 weeks of trial entry. Pregnant or nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods
    - They have given written informed consent.

    Inclusion Criteria for APL Patients:
    - Signed written informed consent
    - Clinical diagnosis of APL and subsequently confirmed to have PML-RARA fusion
    - Age > 15 years
    - WHO performance status 0-2
    - Serum total bilirubin < 2.0 mg/dL (≤51 umol/L)
    - Serum creatinine < 3.0 mg/dL (< 260 μmol/L)
    - Women of child-bearing potential (ie women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence. Intrauterine device (IUD) and must have a negative pregnancy test within 2 weeks of trial entry. Pregnant or nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods.
    E.4Principal exclusion criteria
    Patients are not eligible for the AML17 trial if:
    - They have previously received cytotoxic chemotherapy for AML. [Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.]
    - They are in blast transformation of chronic myeloid leukaemia (CML).
    - Have a LV ejection fraction of <45% (such patients can be placed on to the D(60)A arm
    - They have a concurrent active malignancy.
    - They are pregnant or lactating.
    -The physician and patient consider that intensive therapy is not an appropriate treatment option.

    Exclusion criteria for APL patients:
    - Age < 16
    - Active malignancy at time of study entry
    - Lack of subsequent diagnostic confirmation of PML-RARA fusion at molecular level
    - Significant arrhythmias, ECG abnormalities or neuropathy
    - Cardiac contraindications for intensive chemotherapy (L-VEF <50%)
    - Uncontrolled, life-threatening infections.
    - Severe uncontrolled pulmonary or cardiac disease.
    - Pregnant or lactating.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoints are:

    Complete remission (CR) achievement and reasons for failure (for induction questions).

    Duration of remission, relapse rates and deaths in first CR.

    Overall survival.

    Toxicity, both haematological and non-haematological.

    Quality of life for patients in the disease monitoring randomisation.

    Supportive care requirements (and other aspects of health economics.

    For APL patients, the primary endpoints are:
    - To compare quality of life and toxicity and resource usage of patients receiving the AIDA or the chemo-free treatment of ATRA + Arsenic Trioxide.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Remission status will be assessed during/end of induction therapy and during/end of consolidation therapy, at 1 year follow up and at relapse/death.

    Toxicity will be assessed during and at the end of therapy.

    Quality of life assessments will be done at 3, 6 and 12 months after treatment. APL patients will have quality of life assessments at 3, 6, 12 and 24 months from diagnosis.

    Health economics information on resource usage will be collected during treatment, follow up and at relapse.
    E.5.2Secondary end point(s)
    Blood and bone marrow will be required at diagnosis, during remission and at relapse to evaluate the therapeutic relevance of morphological, cytogenetic, molecular-genetic and immunophenotypic assessments, with particular respect to:
    - The relevance of the molecular and immunophenotypic detection of minimal residual disease.
    - The relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission.
    - To correlate plasma arsenic levels with disease response and treatment-related toxicities including differentiation syndrome in APL patients allocated to receive ATO therapy.
    - To store excess diagnostic material for future research.


    For APL patients, secondary endpoints will be:

    - To compare CR, OS and relapse rates in the two arms.
    - To compare the kinetics of MRD in the two arms.
    - To correlate plasma arsenic levels with disease response and treatment-related toxicities in APL patients allocated to receive arsenic trioxide therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood and bone marrow samples will be collected at diagnosis, during remission and at relapse.

    For APL patients and analysis of plasma arsenic levels, 3 blood samples will be taken during induction therapy.

    For APL patients, bone marrow samples will be taken after each consolidation course and then at 3-monthly intervals for 36 months for MRD monitoring.
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    New Zealand
    United Kingdom
    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.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2800
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2500
    F.4.2.2In the whole clinical trial 2800
    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)
    None.
    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 Decision2013-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
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