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    Summary
    EudraCT Number:2016-001533-28
    Sponsor's Protocol Code Number:AAML0531
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-05-03
    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 number2016-001533-28
    A.3Full title of the trial
    A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Conventional Chemotherapy in combination with or without Gemtuzumab Ozogamicin (Mylotarg) in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia (a serious malignant blood disorder which is fatal if not treated)
    A.4.1Sponsor's protocol code numberAAML0531
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00372593
    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 SponsorChildren's Oncology Group
    B.1.3.4CountryUnited States
    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 supportNational Cancer Institute
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChildren’s Oncology Group
    B.5.2Functional name of contact point Clinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address222 E Huntington Dr., Suite 100
    B.5.3.2Town/ cityMonrovia
    B.5.3.3Post code91016
    B.5.3.4CountryUnited States
    B.5.4Telephone number16264470064
    B.5.5Fax number16264454334
    B.5.6E-mailCTGOV@childrensoncologygroup.org
    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 Mylotarg
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/00/005
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for concentrate 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 INNGemtuzumab ozogamicin
    D.3.9.1CAS number 220578-59-6
    D.3.9.3Other descriptive nameGEMTUZUMAB OZOGAMICIN
    D.3.9.4EV Substance CodeSUB20794
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 myeloid leukaemia
    E.1.1.1Medical condition in easily understood language
    A serious malignant blood disorder which is fatal if not treated
    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
    • Event-free Survival at 3 Years
    • Overall Survival at 3 Years
    E.2.2Secondary objectives of the trial
    • Remission Induction Rate After 2 Courses of Induction Therapy
    • Disease-free Survival
    • Mortality
    • Time to Marrow Recovery
    • Toxicities, Including Infectious Complications
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infants, Children, Adolescents, and Young Adults (<30 year old) with newly diagnosed acute myeloid leukemia (AML).
    E.4Principal exclusion criteria
    Major exclusion criteria included juvenile myelomonocytic leukemia, Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome, promyelocytic leukemia (M3), secondary or treatment-related AML; prior chemotherapy, radiation therapy, or any antileukemic therapy; other prior treatment for AML.
    E.5 End points
    E.5.1Primary end point(s)
    • Overall survival at 3 years, defined as time from study entry, and from
    end of induction course 2 for patients in CR, until death.
    • Event-free survival at 3 years defined as time from study entry until
    death from any cause, induction failure or any relapse of any type
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survival at 3 years, defined as time from study entry, and from
    end of induction course 2 for patients in CR, until death.
    Event-free survival at 3 years defined as time from study entry until
    death from any cause, induction failure or any relapse of any type
    E.5.2Secondary end point(s)
    • Remission rate (RR) after 2 courses of induction therapy
    • Disease-free survival
    • Mortality
    • Time to marrow recovery
    • Toxicities, including infectious complications
    E.5.2.1Timepoint(s) of evaluation of this end point
    Remission rate (RR) after 2 courses of induction therapy- After 2 courses of induction (I and II) therapy, assessed for up to 10 years;
    Disease-free survival: Time from the end of course 3 (Intensification I) to death or relapse; assessed for up to 10 years;
    Mortality: During the first three courses of therapy;
    Time to marrow recovery: At 25 days after treatment with Induction I, Induction II, and Intensification I;
    Toxicities, including infectious complications: From the time therapy is initiated, assessed up to 10 years
    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 Yes
    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) No
    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 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
    Australia
    Canada
    New Zealand
    Puerto Rico
    Switzerland
    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 years14
    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: 1022
    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: 207
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 450
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 300
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    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
    children under the age of 18
    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 1070
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Children’s Oncology Group
    G.4.3.4Network Country United States
    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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