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    Summary
    EudraCT Number:2013-002843-26
    Sponsor's Protocol Code Number:HO132AML/SAKK30/13
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-12
    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 number2013-002843-26
    A.3Full title of the trial
    Randomized study with a run-in dose-selection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score > 4.5)
    Satunnaistettu tutkimus lenalidomidihoidon lisähyödyn selvittämiseksi yhdessä tavanomaisen remissioon tähtäävän kemoterapian ja remission saavuttamisen jälkeisen hoidon osana 18-65 vuotiailla aiemmin hoitamatonta akuuttia myelooista leukemiaa (AML) tai suuren riskin myelodysplasiaa (MDS) (IPSS-R riskiluku> 4,5) sairastavilla potilailla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of effect of adding lenalidomide to standard chemotherapy and post-remission treatment in patients with newly diagnosed acute myeloid leukemia (AML) or high risk myelodysplasia (MDS)
    A.3.2Name or abbreviated title of the trial where available
    HOVON 132 AML/SAKK 30/13
    A.4.1Sponsor's protocol code numberHO132AML/SAKK30/13
    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 SponsorHOVON Foundation
    B.1.3.4CountryNetherlands
    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 supportDutch Cancer Society
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCelgene B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOVON Data Center
    B.5.2Functional name of contact pointHDC
    B.5.3 Address:
    B.5.3.1Street Address´s-Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31107041560
    B.5.5Fax number+31107041028
    B.5.6E-mailhdc@erasmusmc.nl
    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 Revlimid 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    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 Yes
    D.2.1.1.1Trade name Revlimid 15mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    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 Revlimid 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/192 (MDS)
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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.3.8INN - Proposed INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    previously untreated acute myeloid leukemia (AML) or high risk
    myelodysplasie (MDS)
    E.1.1.1Medical condition in easily understood language
    previously untreated acute myeloid leukemia (AML) or high risk
    myelodysplasie (MDS)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10028532
    E.1.2Term Myelodysplasia
    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
    Part A run-in:
    • To select in a randomized approach the feasible dose level of
    lenalidomide when given orally at three variable dose levels (20 mg/ day
    1-21; 30 mg/ day 1-21 and 40 mg/ day 1-21 ) in combination with
    standard induction cycles I and II in patients with AML/ MDS with IPSSR>
    4.5
    Part A:
    • To evaluate the effect of lenalidomide on EFS at the selected (during
    Part A run-in) feasible dose level when combined with remission
    induction chemotherapy cycles I and II in a randomized comparison to
    remission induction cycles I and II without addition of lenalidomide in a
    phase III study
    Part B:
    • To evaluate the effect of 6 cycles of maintenance therapy with
    lenalidomide treatment (10 mg/day for 21 days followed by 14 days
    rest) after post remission chemotherapy cycle III or autoHSCT versus
    observation only
    E.2.2Secondary objectives of the trial
    Part A :
    • To investigate the efficacy of lenalidomide in combination with
    remission induction chemotherapy cycles I and II (compared to the
    same treatment without lenalidomide) in all patients with regard to
    complete remission rate (CR/CRi), DFS, CIR and OS
    • To investigate the clinical efficacy of lenalidomide in combination
    with cycles I and II in molecularly and cytogenetically distinguishable
    subsets with regard to CR/CRi, DFS, CIR and OS
    • To evaluate the treatment effects according to MRD measurements
    following therapy by standardized sampling of marrow/blood following
    remission induction treatment
    Part B:
    • To investigate the clinical efficacy of lenalidomide with regard to DFS
    and OS measured from 2nd randomization
    • To assess post remission and post transplant adverse events and
    need for transfusions when lenalidomide is applied after post remission
    chemotherapy/autoHSCT
    see protocol for full seconday objectives (1700 characters)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-65 years, inclusive
    • Patients with
    o a diagnosis of AML and related precursor neoplasms according to
    WHO 2008 classification (excluding acute promyelocytic leukemia)
    including secondary AML (after an antecedent hematological disease
    (e.g. MDS) and therapy-related AML), or
    o acute leukemia's of ambiguous lineage according to WHO 2008 or
    o a diagnosis of refractory anemia with excess of blasts (MDS) and
    IPSS-R score > 4.5
    • WHO performance status 0, 1 or 2
    • Sampled bone marrow and/ blood cells at diagnosis for centralized
    molecular analysis, MRD evaluation and biobanking, unless in case of a
    dry marrow tap with no possibility to collect marrow cells. In cases of
    marrow tap failure only blood cells will be sampled.
    • Adequate renal and hepatic functions unless clearly disease related as
    indicated by the following laboratory values:
    o Serum creatinine ≤1.0 mg/dL (≤88.7 μmol/L); if serum creatinine
    >1.0 mg/dL (>88.7 μmol/L), then the estimated glomerular filtration
    rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the
    Modification of Diet in Renal Disease equation where Predicted GFR
    (ml/min/1.73 m2) = 186 x (Serum Creatinine in mg/dL)-1.154 x (age in
    years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black)
    NOTE: if serum creatinine is measured in umol/L, recalculate it in
    mg/dL according to the equation: 1 mg/dL = 88.7 umol/L) and use
    above mentioned formula.
    o Serum bilirubin ≤2.5 x upper limit of normal (ULN)
    o Aspartate transaminase (AST) ≤ 2.5 x ULN
    o Alanine transaminase (ALT) ≤ 2.5 x ULN
    o Alkaline phosphatase ≤ 2.5 x ULN
    • Written informed consent
    • Ability to adhere to the lenalidomide Pregnancy Prevention Program
    Part B:
    • CR or CRi
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 75 x 109/L
    • Serum creatinine clearance ≥ 30 ml/min
    E.4Principal exclusion criteria
    • Previous therapy with lenalidomide
    • Acute promyelocytic leukemia
    • Myeloproliferative neoplasia
    • Previous treatment for AML or high risk MDS (IPSS-R > 4.5), except
    hydroxyurea
    • Concurrent history of active malignancy in two past years prior to
    diagnosis except for:
    o basal and squamous cell carcinoma of the skin
    o in situ carcinoma of the cervix
    • Concurrent severe and/or uncontrolled medical condition (e.g.
    uncontrolled diabetes, infection, hypertension, pulmonary disease
    etcetera)
    • Cardiac dysfunction as defined by:
    o Myocardial infarction within the last 6 months of study entry, or
    o Reduced left ventricular function with an ejection fraction < 50% as
    measured by MUG scan or echocardiogram or
    o Unstable angina, or
    o Unstable cardiac arrhythmias
    • Pregnant or lactating females
    • Unwilling or not capable to use effective means of birth control
    • Any psychological, familial, sociological and geographical condition
    potentially hampering compliance with the study protocol and follow-up
    schedule
    Part B:
    • Severe cardiac dysfunction (NYHA classification II-IV, see appendix
    G)
    • Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix F)
    • Severe neurological or psychiatric disease
    • Serious active infections
    • Previous serious toxicities related to the use of lenalidomide
    • CMV reactivation, which is not responsive to first line valganciclovir
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint Part A-run-in: Lenalidomide dose level selection
    • DLT and duration of myelosuppression of induction treatment with or
    without lenalidomide for each of the distinct predefined dose levels
    Primary endpoint Part A: Induction - Efficacy
    • EFS after induction treatment with or without lenalidomide (i.e., time
    from registration to induction failure, death from any cause or relapse
    whichever occurs first)
    Primary endpoint Part B: Maintenance - Efficacy
    • Cumulative incidence of relapse (CIR) after second randomization
    (maintenance treatment with lenalidomide or observation only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial. After last patient has completed maintenance
    treatment.
    E.5.2Secondary end point(s)
    Secondary endpoints Part A Run-in : Lenalidomide dose level selection
    • Response (CR and CRi) after induction therapy cycles I and II
    Secondary endpoints Part A: Induction- Efficacy
    • EFS in the distinct prognostic subsets (AML good-risk vs. AML
    intermediate-risk vs. AML poor-risk vs. AML-very poor-risk) and cytogenetically and molecularly defined subgroups of AML
    • Response (CR and CRi) after induction therapy cycles I and II
    • Disease-free survival (DFS, measured from time of CR/CRi to day of
    relapse or death from any cause, whichever occurs first)
    • OS measured from the time of registration
    • Outcome of induction treatments in relation to MRD measurements
    • Evaluation of molecular prognostic markers and gene expression
    profiles for and overexpression of defined genes (e.g. EVI1, cereblon) for
    outcome in relation to induction and post induction treatments
    • Toxicities
    • Evaluation of MRD after induction and post-induction treatments
    • Time to hematopoietic recovery (ANC 0.5 and 1.0 x 109/L; platelets
    50 and 100 x 109/L) after each treatment cycle
    • Number of platelet transfusions and last day of platelet transfusion
    after each cycle
    • Impact of the use of lenalidomide on the effectiveness of stem cell mobilization
    Secondary endpoints Part B: Maintenance - efficacy
    • OS and DFS measured from 2nd randomization, and also in the
    distinct prognostic subsets (AML good-risk vs. AML intermediate-risk vs.
    AML poor-risk vs. AML very poor-risk) and cytogenetically and
    molecularly defined subgroups of AML
    • Toxicities
    • Number of platelet transfusions and last day of platelet transfusion
    after each cycle
    • Number of RBC transfusions in relation to maintenance or no
    maintenance treatment
    • Evaluation of MRD after 2nd randomization
    • Time to hematopoietic recovery (ANC 0.5 and 1.0x109/L; platelets 50 and 100x109/L) after each treatment cycle
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial. After last patient has completed maintenance
    treatment.
    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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    compared to standard therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Estonia
    Lithuania
    Netherlands
    Norway
    Sweden
    Switzerland
    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 years7
    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 years8
    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: 573
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 287
    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.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 860
    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 HOVON Foundation
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-27
    P. End of Trial
    P.End of Trial StatusOngoing
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