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    Summary
    EudraCT Number:2009-013094-17
    Sponsor's Protocol Code Number:HOVON103AMLLEN
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-08-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-013094-17
    A.3Full title of the trial
    A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years.

    A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study for the treatment of patients with leukemic cells in their bone marrow.
    A.3.2Name or abbreviated title of the trial where available
    HOVON 103 AML Lenalidomide
    A.4.1Sponsor's protocol code numberHOVON103AMLLEN
    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 supportHOVON Foundation
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCELGENE International
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointHOVON Data Center
    B.5.3 Address:
    B.5.3.1Street AddressP.O. Box 5201
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3008 AE
    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, 5 mg capsule
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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.3.9.2Current sponsor codeRV 0428
    D.3.9.3Other descriptive nameRevlimid
    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 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) 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, 10 mg capsule
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRevlimid
    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.3.9.2Current sponsor codeRV 0428
    D.3.9.3Other descriptive nameRevlimid
    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.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
    patients ≥ 66 years.with a confirmed diagnosis of
    o AML (not APL) (see appendix A) or
    o refractory anemia with excess of blasts (RAEB) with an IPSS score ≥ 1.5
    OR
    Patients of any age ≥ 18 years with a confirmed diagnosis of
    o AML with very poor risk AML
    E.1.1.1Medical condition in easily understood language
    Leukemia, cancer of bone marrow
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10037803
    E.1.2Term RAEB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For part A of the study (if applicable):
    1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) and select the feasible dose level for part B
    2. To assess in a randomized comparison the effect of lenalidomide on the CR rate.

    For part B:
    1. To assess the safety and tolerability of lenalidomide added to standard induction chemotherapy for AML (frequency and severity of toxicities and the durations of neutropenia and thrombocytopenia) as regards the selected dose level of lenalidomide
    2. To assess in a randomized comparison the effect of lenalidomide on the CR rate.

    E.2.2Secondary objectives of the trial
    For part B:
    1. To determine the efficacy profile (event free survival and disease free survival and overall survival) associated with the two therapy regimens.
    2. To measure MRD by immunophenotyping in relation to clinical response parameters.
    3. To identify potential biomarkers predictive of response, event free survival and disease free survival by exploratory proteomic and genomic analysis (microarray, gene mutations)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients eligible for standard chemotherapy.
    - Patients ≥ 66 years.with a cytopathologically confirmed diagnosis according WHO classification of
    o AML (not APL) (see appendix A) or
    o refractory anemia with excess of blasts (RAEB) with an IPSS score ≥ 1.5
    OR
    - Patients of any age ≥ 18 years with cytopathologically confirmed diagnosis according WHO classification of
    o AML with very poor risk AML
    - Subjects with secondary AML progressing from antecedent (at least 4 months
    duration) myelodysplasia are also eligible.
    - SGOT (AST) and SGPT (ALT) <= 1.5 x the upper limit of the normal range (ULN) at the laboratory where the analyses were performed.
    - Total serum bilirubin level <= 1.5 x the ULN at the laboratory where the analysis was
    performed.
    - Serum creatinine concentration <= 1.5 x the ULN at the laboratory where the
    analysis was performed.
    - WHO performance status ≤ 2
    - Written informed consent.
    - Female patients of childbearing potential must have a negative serum pregnancy
    test within 2 weeks prior to enrollment.
    - Male and female patients must use an effective contraceptive method during the
    study and for a minimum of 6 months after study treatment.(see protocol appendix J for more information and specific requirements)

    E.4Principal exclusion criteria
    -Acute promyelocytic leukemia
    - Patients previously treated for AML (any antileukemic therapy including
    investigational agents), a short treatment period (< 2 weeks) with Hydroxyurea is
    allowed
    - Past or current history (within the last 2 years prior to randomization) of
    malignancies except for the indication under this study and curatively treated:
    - Basal and squamous cell carcinoma of the skin
    - in situ carcinoma of the cervix
    - Blast crisis of chronic myeloid leukemia
    - Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular
    accidents (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months
    prior to randomization), unstable angina, New York Heart Association (NYHA) grade
    II or greater congestive heart failure,
    - Patients with a history of non-compliance to medical regimens or who are
    considered unreliable with respect to compliance
    - Patients with any serious concomitant medical condition which could, in the opinion
    of the investigator, compromise participation in the study.
    - Patients who have senile dementia, mental impairment or any other psychiatric
    disorder that prohibits the patient from understanding and giving informed consent.
    - Pregnant or lactating patients.
    - Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of DLT (part A)
    - The effect of lenalidomide on the CR rate (part B of study)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis of the primary endpoints will be done one year after
    last patient is registered in the lenalidomide arm.
    E.5.2Secondary end point(s)
    1. To determine the efficacy profile (event free survival (EFS) disease free survival (DFS) and overall survival (OS)) associated with the two therapy regimens.
    2. To measure MRD by immunophenotyping in relation to clinical response parameters.
    3. To identify potential biomarkers predictive of response, EFS, DFS and OS by exploratory genomic analysis (microarray, gene mutations)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analysis of the secondary endpoints will be done one year after last patient is registered in the lenalidomide arm.
    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 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
    addition of lenalidomide
    E.8.2.4Number of treatment arms in the trial2
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Netherlands
    Norway
    Switzerland
    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
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-08-18. Yes
    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 state168
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 240
    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)
    see protocol
    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 Decision2009-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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