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    Clinical Trial Results:
    Pilot safety/tolerability study of Lenalidomide administered as monotherapy and in combination with standard chemotherapy for Acute Myeloid Leukaemia/high-risk Myelodysplastic Syndrome with structural abnormalities of chromosome 5

    Summary
    EudraCT number
    2008-004891-28
    Trial protocol
    GB  
    Global end of trial date
    31 Jul 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Feb 2016
    First version publication date
    28 Feb 2016
    Other versions
    Summary report(s)
    End of Trial report

    Trial information

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    Trial identification
    Sponsor protocol code
    HM08 / 8451
    Additional study identifiers
    ISRCTN number
    ISRCTN58492795
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Leeds Teaching Hospitals NHS Trust
    Sponsor organisation address
    34 Hyde Terrace, Leeds, United Kingdom, LS2 9LN
    Public contact
    CTRU QA department, Leeds Institute of Clinical Trials Research, 0113 34331477, medctruq@leeds.ac.uk
    Scientific contact
    CTRU QA department, Leeds Institute of Clinical Trials Research, 0113 34331477, medctruq@leeds.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Jan 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess safety, tolerability and efficacy of the combination of oral Lenalidomide administered as a single agent and simultaneously with induction chemotherapy using Cytosine Arabinoside, Daunorubicin +/- Etoposide (ADE) for patients with AML/MDS and chromosome 5 cytogenetic abnormalities.
    Protection of trial subjects
    All chemotherapy treatment involves some side effects as well as potential benefits. The side effects will be monitored closely and the dose adjusted to minimise these. It is not expected that patients will have all these side effects and it is not possible to predict which ones patients will experience or how severe or serious they may be. If a patient experiences a severe reaction, then the study treatment may be discontinued and alternative treatment will be recommended. Currently, all drugs used to treat AML/MDS have potential side effects. The possible side effects of the drugs used in this study are detailed in the patient information sheet. The potential for pain, discomfort or distress is no more than is usual for other patients receiving treatment for AML/MDS. Patients may experience side effects from their treatment and will undergo blood tests and medical assessments. However, these are all part of standard patient management. Patients will need to attend hospital as an inpatient during the combination chemotherapy and allogeneic transplant stages, but this would be required even if they were not taking part in the trial. The bone marrow tests are potentially painful. This trial only requires samples to be taken at the same timepoints as would be required for routine clinical management. The CTRU will comply with all aspects of Data Protection Act 1998. All information collected during the course of the trial will be kept strictly confidential.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Aug 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    6
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    14
    Number of subjects completed
    14

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Lenalidomide monotherapy
    Arm description
    Lenalidomide monotherapy followed by a combination of Lenalidomide and intensive intravenous chemotherapy
    Arm type
    Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Cycle 1: Days 1 – 21 10mg Lenalidomide p.o / day. Days 22-28 Rest Period

    Number of subjects in period 1
    Lenalidomide monotherapy
    Started
    14
    Completed
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    14 14
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    6 6
        From 65-84 years
    8 8
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    65.5 (40 to 75) -
    Gender categorical
    Units: Subjects
        Female
    7 7
        Male
    7 7

    End points

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    End points reporting groups
    Reporting group title
    Lenalidomide monotherapy
    Reporting group description
    Lenalidomide monotherapy followed by a combination of Lenalidomide and intensive intravenous chemotherapy

    Primary: Early death rate

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    End point title
    Early death rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    ≤ 30 days since start of combination chemotherapy
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this primary endpoint due to the trial having one treatment group and therefore no comparator. The results from this primary end point have been entered into the ‘end point values’ section within ‘end point definitions’.
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    9
    Units: Rate
    0
    No statistical analyses for this end point

    Primary: Platelet recovery and survival 42 days from last dose of the first course of the combination chemotherapy

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    End point title
    Platelet recovery and survival 42 days from last dose of the first course of the combination chemotherapy [2]
    End point description
    End point type
    Primary
    End point timeframe
    42 days from last dose of the first course of the combination chemotherapy
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this primary endpoint due to the trial having one treatment group and therefore no comparator. The results from this primary end point have been entered into the ‘end point values’ section within ‘end point definitions’.
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    9
    Units: Number
    2
    No statistical analyses for this end point

    Primary: Complete remission rate

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    End point title
    Complete remission rate [3]
    End point description
    End point type
    Primary
    End point timeframe
    day 21 post the last cycle of lenalidomide plus intensive chemotherapy
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified for this primary endpoint due to the trial having one treatment group and therefore no comparator. The results from this primary end point have been entered into the ‘end point values’ section within ‘end point definitions’.
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    9
    Units: Number
    3
    No statistical analyses for this end point

    Secondary: Response rates for each cycle

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    End point title
    Response rates for each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Number
        Complete Response (CR)
    0
        CR with incomplete haematopoietic recovery (CRi)
    0
        Partial Response (PR)
    0
        No Response (NR)
    5
        Progressive Disease (PD)
    7
        HI-E
    1
        Missing
    1
    No statistical analyses for this end point

    Secondary: Neutrophil and platelet recovery

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    End point title
    Neutrophil and platelet recovery
    End point description
    End point type
    Secondary
    End point timeframe
    42 days post monotherapy
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Number
    5
    No statistical analyses for this end point

    Secondary: Blood product usage (number of blood transfusions)

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    End point title
    Blood product usage (number of blood transfusions)
    End point description
    End point type
    Secondary
    End point timeframe
    cycle 1
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Blood transfusion units
        arithmetic mean (standard deviation)
    4.8 ± 4
    No statistical analyses for this end point

    Secondary: Days in hospital

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    End point title
    Days in hospital
    End point description
    End point type
    Secondary
    End point timeframe
    cycle 1
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Day visits to hospital
        arithmetic mean (standard deviation)
    4.5 ± 2.85
    No statistical analyses for this end point

    Secondary: Days on antibiotics

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    End point title
    Days on antibiotics
    End point description
    End point type
    Secondary
    End point timeframe
    cycle 1
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Days
        arithmetic mean (standard deviation)
    7.1 ± 9.69
    No statistical analyses for this end point

    Secondary: Toxicity

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    End point title
    Toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    in the trial
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Number of participants reporting SAE
    9
    No statistical analyses for this end point

    Secondary: Proportion of patients proceeding to allograft/DLI/maintenance therapy

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    End point title
    Proportion of patients proceeding to allograft/DLI/maintenance therapy
    End point description
    End point type
    Secondary
    End point timeframe
    in the trial
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Number
    1
    No statistical analyses for this end point

    Secondary: Survival

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    End point title
    Survival
    End point description
    End point type
    Secondary
    End point timeframe
    in the trial
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Number of deaths
        Treatment-related
    4
        Non-treatment-related
    9
    No statistical analyses for this end point

    Secondary: Relapse-free survival

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    End point title
    Relapse-free survival
    End point description
    End point type
    Secondary
    End point timeframe
    in the trial
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    4
    Units: Number relapsed
    1
    No statistical analyses for this end point

    Secondary: AML transformation of MDS

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    End point title
    AML transformation of MDS
    End point description
    End point type
    Secondary
    End point timeframe
    in the trial
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    4
    Units: Number
    1
    No statistical analyses for this end point

    Secondary: Haematological improvement for each cycle in patients with MDS

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    End point title
    Haematological improvement for each cycle in patients with MDS
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    4
    Units: Number
        No
    2
        Yes - HI-E
    1
        Yes - HI-P
    1
        Yes - HI-N
    0
    No statistical analyses for this end point

    Secondary: Blood product usage (number of platelet transfusions)

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    End point title
    Blood product usage (number of platelet transfusions)
    End point description
    End point type
    Secondary
    End point timeframe
    cycle 1
    End point values
    Lenalidomide monotherapy
    Number of subjects analysed
    14
    Units: Platelet transfusion units
        arithmetic mean (standard deviation)
    5.3 ± 5.99
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    ARs- time of start of protocol treatment until 30 days post cessation of trial therapy for patients receiving chemotherapy / maintenance. SAEs and SUSARS until 30 days post last trial treatment or 100 days post transplant
    Adverse event reporting additional description
    For ARs only data relating to Neuropathy and Thromboembolic events will be collected following an allogeneic stem cell transplant/DLI and this will be collected until 100 days post transplant/DLI.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See attached end of trial report submitted to the MHRA on 06/05/2014 for details of adverse events. Leeds Institute of Clinical Trials Research is an academic trials unit where full MedDRA coding is not the standard. It has therefore not been possible for adverse event data to be accurately entered into the full data view within EudraCT as all mandatory categories cannot be completed.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2009
    - Change in AE reporting definition -Change in exclusion criteria following on from DMEC advise
    08 Jul 2010
    - Study design amended to remove the monotherapy phase for patients with ≥5% blasts following on from the temporary halt of the trial. The trial was reopened with this amended design.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 May 2010
    Halt due to the trigger of a protocol defined stopping rule for treatment-related deaths in the lenalidomide monotherapy phase for patients with ≥5% blasts.
    28 Jul 2010

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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