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    Clinical Trial Results:
    A double-blind, placebo-controlled, randomized, multicenter phase II trial to assess the efficacy of temsirolimus added to standard primary therapy in elderly patients with newly diagnosed AML

    Summary
    EudraCT number
    		 2011-002365-37
    Trial protocol
    		 DE  
    Global end of trial date
    26 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Oct 2021
    First version publication date
    06 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3066K1-1165
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01611116
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Goethe University
    Sponsor organisation address
    Theodor-Stern-Kai 7, Frankfurt am Main, Germany, 60590
    Public contact
    Prof Christian Brandts, MD, Lead PI, J.W. Goethe University Hospital, 0049 69 6301 7104, Christian.brandts@kgu.de
    Scientific contact
    Prof Christian Brandts, MD, Lead PI, J.W. Goethe University Hospital, 0049 69 6301 7104, Christian.brandts@kgu.de
    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
    21 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Run-in part; To detemine the optimal temsirolimus dose and schedule for the main part of the study Main part: To compare the median Event Free Survival (EFS) And the EFS probability of all AML patients between the temsirolimus and the control group * EFS defined as: Time interval from day 1 of study treatment until treatment failure, relapse from CR or CRi, or death from any cause, whichever occurs first. The time point at which the patient is resistant to therapy or survives induction without a CR, CRi or morphologic leukemia-free state will be recorded.
    Protection of trial subjects
    Data safety monitoring board to decide on optimal dose for main part as well as on serious adverse events with unclear relation to the study drug
    Background therapy
    		 Induction I (7+3): Cytarabine 100mg/m2/24hrs i.v. day 1-7 Daunorubicin 60mg/m2 i.v. day 3-5 Induction II (HAM elderly) for patients with PR or treatment failure: Cytarabin (HD-AraC) 1g/m2/3hrs i.v. (2 x daily) day 1, 3, 5 Mitoxantrone 10mg/m2 i.v. day 3-5 Consolidation I (high-dose cytarabine): Cytarabine (HD-AraC) 1g/m2/3hrs i.v. (2 x daily) day 1, 3, 5 Consolidation II (high-dose cytarabine): Cytarabine (HD-AraC) 1g/m2/3hrs i.v. (2 x daily) day 1, 3, 5
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    22 Jun 2012
    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
    Germany: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    9
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient were recruited by treating physician/investigator upon relevant diagnosis at the hospital

    Pre-assignment
    Screening details
    		 additional screening procedures compared to standard diagnostics: informed consent, laboratory test: troponin T / troponin I, CK, CK-MB, NT-proBNP

    Period 1
    Period 1 title
    Run-in part (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Randomized not controlled, 3 experiemental arms with different doselevels (cohort 1; cohort 2; cohort 3)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 temsirolimus 12.5mg on day -1 of each chemotherapy cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temsirolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cohort 1: temsirolimus 12.5mg on day -1 of each chemotherapy cycle Cohort 2: temsirolimus 12.5mg on day -1 and day 8 of each chemotherapy cycle Cohort 3: temsirolimus 25mg on day -1 and day 8 of each chemotherapy cycle

    Arm title
    		 Cohort 2
    Arm description
    		 temsirolimus 12.5mg on day -1 and day 8 of each chemotherapy cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temsirolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cohort 1: temsirolimus 12.5mg on day -1 of each chemotherapy cycle Cohort 2: temsirolimus 12.5mg on day -1 and day 8 of each chemotherapy cycle Cohort 3: temsirolimus 25mg on day -1 and day 8 of each chemotherapy cycle

    Arm title
    		 Cohort 3
    Arm description
    		 temsirolimus 25mg on day -1 and day 8 of each chemotherapy cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Temsirolimus
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cohort 1: temsirolimus 12.5mg on day -1 of each chemotherapy cycle Cohort 2: temsirolimus 12.5mg on day -1 and day 8 of each chemotherapy cycle Cohort 3: temsirolimus 25mg on day -1 and day 8 of each chemotherapy cycle

    Number of subjects in period 1
    		Cohort 1 Cohort 2 Cohort 3
    Started
    5
    17
    11
    DLT (cohort 1; cohort 2; cohort 3)
    3
    9
    7
    Completed
    3
    9
    7
    Not completed
    2
    8
    4
         Consent withdrawn by subject
    1
    2
    -
         Physician decision
    1
    2
    -
         pt died before 1st dose was administered
    -
    -
    1
         Lost to follow-up
    -
    1
    -
         Lack of efficacy
    -
    1
    3
         Protocol deviation
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Run-in part
    Reporting group description
    		 -

    Reporting group values
    		 Run-in part Total
    Number of subjects
    		 33 33
    Age categorical
    All patients enrolled in the run-in part regardless of evaluability
    Units: Subjects
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 24 24
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 19 19
    Subject analysis sets

    Subject analysis set title
    Run-in part
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients enrolled in the run-in part regardless of evaluability

    Subject analysis sets values
    		 Run-in part
    Number of subjects
    33
    Age categorical
    All patients enrolled in the run-in part regardless of evaluability
    Units: Subjects
        Adults (18-64 years)
    9
        From 65-84 years
    24
        85 years and over
    0
    Age continuous
    All patients enrolled in Arm 1 (N=5)
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    14
        Male
    19

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 temsirolimus 12.5mg on day -1 of each chemotherapy cycle

    Reporting group title
    Cohort 2
    Reporting group description
    		 temsirolimus 12.5mg on day -1 and day 8 of each chemotherapy cycle

    Reporting group title
    Cohort 3
    Reporting group description
    		 temsirolimus 25mg on day -1 and day 8 of each chemotherapy cycle

    Subject analysis set title
    Run-in part
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients enrolled in the run-in part regardless of evaluability

    Primary: Optimal temsirolimus dose and schedule

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    End point title
    		 Optimal temsirolimus dose and schedule [1]
    End point description
    According to the definition in the protocol, dose level / mode of application in cohort I and cohort II could be evaluated as being safe. Eleven patients were enrolled in cohort III. Due to a simultaneous patient screening, seven evaluable patients were eventually included. Two DLTs were observed: Mucositis oral grade 3 and Mucositis/colitis grade 3 with suspected relationship. Multiple incidences of mucositis grade 3 both in cohort II (1 DLT and 1 not evaluable patient with SAE mucositis oral grade 3 with suspected relationship to study drug) and cohort III suggest that temsirolimus may cause increased mucosal toxicity when administered in combination with 7+3 standard therapy. After reassessing the risk benefit ratio, the co-ordinating investigator in line with the data safety monitoring board decided not to enroll any additional patients in cohort III thus giving priority to the patients’ safety over formal requirements of the 3+3 design.
    End point type
    Primary
    End point timeframe
    Run-in part
    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: Only desciptive analysis!
    End point values
    		 Cohort 1 Cohort 2 Cohort 3
    Number of subjects analysed
    4 [2]
    9 [3]
    7 [4]
    Units: ng
    12500
    12500
    25000
    Notes
    [2] - Dose: 12,5 mg
    [3] - Dose: 12,5 mg
    [4] - Dose: 25 mg
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From enrolment until 30 days following last dose of study treatment or 42 days after last dose of study treatment (for neutropenia and thrombocytopenia)
    Adverse event reporting additional description
    Not applicable
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Run-in part
    Reporting group description
    		 -

    Serious adverse events
    		 Run-in part
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 29 (48.28%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    3
    Cardiac disorders
    Heart failure
    Additional description: Not applicable
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    1 / 1
    Nervous system disorders
    Intracranial hemorrhage
    Additional description: Epidural hematoma
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Allergic reaction
    Additional description: dyspnea, facial rash, fever + shivering
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Small intestinal mucositis
    Additional description: Not applicable
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower gastrointestinal hemorrhage
    Additional description: Peranal bleeding
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
    Additional description: Not applicable
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspiration
    Additional description: Not applicable
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Lung infection
    Additional description: Not applicable
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sepsis
    Additional description: Sepsis in neutropenia
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hypernatremia
    Additional description: Not applicable
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Run-in part
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 29 (100.00%)
    Vascular disorders
    Hematoma
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Hypertension
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    7
    Phlebitis
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Edema face
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Edema limbs
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    17
    Fatigue
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    5
    Fever
         subjects affected / exposed
    17 / 29 (58.62%)
         occurrences all number
    26
    Infusion related reaction
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    Infusion site extravasation
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Injection site reaction
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    6
    Localized edema
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    5
    Multi-organ failure
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Pain
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    8 / 29 (27.59%)
         occurrences all number
    18
    Respiratory, thoracic and mediastinal disorders
    cough
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    9
    Dyspnea
         subjects affected / exposed
    10 / 29 (34.48%)
         occurrences all number
    12
    Epistaxis
         subjects affected / exposed
    16 / 29 (55.17%)
         occurrences all number
    18
    Pleural effusion
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Pneumonitis
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    4
    Pulmonary edema
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Sore throat
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    6
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    4
    Confusion
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Delirium
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    Depression
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Investigations
    Investigations - Other, specify (CRP)
    Additional description: CRP increase
         subjects affected / exposed
    5 / 29 (17.24%)
         occurrences all number
    5
    Investigations - Other, specify (TPZ)
    Additional description: TPZ decrease
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Neutrophil count decreased
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Platelet count decreased
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    8
    Weight loss
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    White blood cell decreased
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    12 / 29 (41.38%)
         occurrences all number
    12
    Syncope
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    8 / 29 (27.59%)
         occurrences all number
    8
    Febrile neutropenia
         subjects affected / exposed
    12 / 29 (41.38%)
         occurrences all number
    20
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    Eye disorders
    Vitreous hemorrhage
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Dry eye
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    5
    Bloating
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Colitis
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    8 / 29 (27.59%)
         occurrences all number
    11
    Diarrhea
         subjects affected / exposed
    19 / 29 (65.52%)
         occurrences all number
    22
    Dry mouth
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Mucositis oral
         subjects affected / exposed
    21 / 29 (72.41%)
         occurrences all number
    23
    Nausea
         subjects affected / exposed
    8 / 29 (27.59%)
         occurrences all number
    10
    Oral hemorrhage
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Oral pain
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Stomach pain
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    11 / 29 (37.93%)
         occurrences all number
    19
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Palmar-plantar erythrodysesthesia syndrome
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    Purpura
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    5
    Skin ulceration
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    3
    Urinary incontinence
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    1 / 29 (3.45%)
         occurrences all number
    2
    Infections and infestations
    Infections and infestations - Other, specify (CRP)
    Additional description: CRP increased
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Bladder infection
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Catheter related infection
         subjects affected / exposed
    6 / 29 (20.69%)
         occurrences all number
    6
    Lip infection
         subjects affected / exposed
    6 / 29 (20.69%)
         occurrences all number
    7
    Lung infection
         subjects affected / exposed
    7 / 29 (24.14%)
         occurrences all number
    7
    Mucosal infection
         subjects affected / exposed
    6 / 29 (20.69%)
         occurrences all number
    7
    Papulopustular rash
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Skin infection
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Tooth infection
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    4 / 29 (13.79%)
         occurrences all number
    4
    Hyperglycemia
         subjects affected / exposed
    3 / 29 (10.34%)
         occurrences all number
    3
    Hyperkalemia
         subjects affected / exposed
    2 / 29 (6.90%)
         occurrences all number
    2
    Hypokalemia
         subjects affected / exposed
    18 / 29 (62.07%)
         occurrences all number
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 May 2013
    Study design • Increase of number of patients in run-in part • Implementation of dose-escalating study design with three consecutive cohorts • Definition of Dose Limiting Toxicity • Changes in definition of non-hematological DLT • Changes in definition of evaluability for DLT assessment Definition of Dose Limiting Toxicity • Changes in definition of non-hematological DLT • Changes in definition of evaluability for DLT assessment Treatment • Modification of scheme of run-in part • Modification of treatment schedule for induction chemotherapy • Modification of treatment schedule for induction II chemotherapy • Modification of treatment schedule for consolidation chemotherapy I and II Dose modification and delays of temsirolimus / placebo • Dose modifications for non-hematological toxicity • Instructions for safety evaluations and dose modification in patients with cardiac disorders • Instructions for dose modification in patients with mucositis

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Jul 2012
    Interruption of accrual after two SUSAR (Heart failure) in ordert o re-evaluate patient safety
    05 Sep 2013

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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