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    Clinical Trial Results:
    Sub-cutaneous Rituximab-miniCHOP versus Sub-cutaneous Rituximab-miniCHOP + lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for patients of 80 years old or more. A multicentric phase III study of the LYSA.

    Summary
    EudraCT number
    		 2013-000450-22
    Trial protocol
    		 BE   PT  
    Global end of trial date
    07 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jan 2023
    First version publication date
    08 Jan 2023
    Other versions
    Summary report(s)
    		 SENIOR synopsis CSR

    Trial information

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    Trial identification
    Sponsor protocol code
    SENIOR
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02128061
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LYSARC
    Sponsor organisation address
    Centre Hospitalier Lyon-Sud Bâtiment 2D, Pierre Benite, France,
    Public contact
    Elisa CHAREYRE, LYSARC, 33 (0)4 27 01 27 25, elisa.chareyre.ext@lysarc.org
    Scientific contact
    Fabrice JARDIN, LYSA, 33 (0)276673052, fabrice.jardin@chb.unicancer.fr
    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
    28 Jul 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective of the study is to compare the efficacy of R2-miniCHOP and R-miniCHOP in patients ≥ 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OS)
    Protection of trial subjects
    In case of deep vein thrombosis (DVT) occurrence, antithrombotic treatment (heparin or Coumadin [INR 2-3]) must be started (and kept during the whole treatment duration with lenalidomide) and lenalidomide can be resumed without dose reduction. If DVT is not resolved or in case of DVT recurrence, lenalidomide must be stopped and the decision of maintaining the R-miniCHOP regimen stays at the investigator’s discretion.
    Background therapy
    		 R-miniCHOP
    Evidence for comparator
    		 In Phase II study of the GELA group involving patients older than 80 years, the efficacy and safety of a decreased dose of CHOP (doxorubicin, cyclophosphamide, vincristine, and prednisone) chemotherapy with a conventional dose of rituximab (R-miniCHOP) was recently investigated. After a median follow-up of 20 months, analysis by intention to treat of the 149 included patients demonstrated a 2-year overall survival of 59%, a 2-year PFS of 47% and a median progression-free survival of 21 months. The most frequent side-effect was haematological toxicity (grade ≥ 3 neutropenia in 40% of cases) but with infrequent febrile neutropenia (7%) indicating that R-miniCHOP displays a good compromise between efficacy and safety in this population10. This regimen can be considered as the current gold standard for fit patients older than 80 years. According to further multivariate analysis performed for this study (not published), survival of patients less than 85 years was significantly different from patients aged of more than 85 years old. Similar results were obtained in a 70% CHOP reduction regimen for patients older than 70, displaying a 3-year PFS of 72% and a 3-year OS of 58%21. Activity and safety of dose-adjusted infusional cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (DA-EPOCH) with rituximab in elderly patients with poor-prognostic untreated DLBCL has been also proposed in frail patients older than 70 years. To date, the R-miniCHOP (with rituximab IV) regimen is the standard of care for fit DLBCL patients > 80y and will be the standard arm of the trial.
    Actual start date of recruitment
    31 Mar 2014
    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
    Portugal: 1
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    France: 237
    Worldwide total number of subjects
    249
    EEA total number of subjects
    249
    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)
    0
    From 65 to 84 years
    188
    85 years and over
    61

    Subject disposition

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    Recruitment
    Recruitment details
    		 250 patients were randomized at 71 study centers in France, Belgium and Portugal from August 20th, 2014 to September 13th, 2017.

    Pre-assignment
    Screening details
    		 In both arms, before the start of the treatment and after randomization, a pre-phase treatment was administered to the patients one week before D1 of chemotherapy. Chemotherapy regimen : -Prednisone 60 mg/m2 at D-7 D-6 D-5 D-4 -Vincristine 1 mg TD at D-7

    Period 1
    Period 1 title
    Pre-Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R-mini chop
    Arm description
    		 Standard Arm : All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D1) DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) *The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2
    Arm type
    		 Standard

    Investigational medicinal product name
    VINCRISTINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg TD

    Investigational medicinal product name
    PREDNISONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/m2

    Arm title
    		 R2-minichop
    Arm description
    		 Experimental Arm : All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) LENALIDOMIDE PO** (10 mg TD from D1 to D14)
    Arm type
    		 Experimental

    Investigational medicinal product name
    VINCRISTINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg TD

    Investigational medicinal product name
    PREDNISONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg/m2

    Number of subjects in period 1
    		R-mini chop R2-minichop
    Started
    127
    122
    Completed
    127
    122
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R-mini chop
    Arm description
    		 Standard Arm : All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D1) DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) *The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2
    Arm type
    		 Standard

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Solution for injection , Subcutaneous use
    Dosage and administration details
    375 mg/m2 1400 mg TD

    Investigational medicinal product name
    CYCLOPHOSPHAMIDE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m²

    Investigational medicinal product name
    DOXORUBICINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Solution for injection
    Dosage and administration details
    25 mg/m²

    Investigational medicinal product name
    VINCRISTINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg TD

    Investigational medicinal product name
    PREDNISONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/m²

    Arm title
    		 R2-minichop
    Arm description
    		 Experimental Arm : All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) LENALIDOMIDE PO** (10 mg TD from D1 to D14)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg TD

    Investigational medicinal product name
    CYCLOPHOSPHAMIDE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/m²

    Investigational medicinal product name
    VINCRISTINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg TD

    Investigational medicinal product name
    DOXORUBICINE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Solution for injection
    Dosage and administration details
    25 mg/m²

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Solution for injection , Subcutaneous use
    Dosage and administration details
    375 mg/m2 1400 mg TD

    Number of subjects in period 2
    		R-mini chop R2-minichop
    Started
    127
    122
    Completed
    100
    101
    Not completed
    27
    21
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    7
    6
         Death
    5
    2
         Progression
    9
    3
         other
    -
    1
         Toxicity of study treatment
    2
    5
         voluntary treatment discontinuation
    -
    1
         Protocol deviation
    1
    1
         Lack of efficacy
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pre-Phase
    Reporting group description
    		 -

    Reporting group values
    		 Pre-Phase Total
    Number of subjects
    		 249 249
    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)
    		 0 0
        From 65-84 years
    		 188 188
        85 years and over
    		 61 61
    Gender categorical
    Units: Subjects
        Female
    		 136 136
        Male
    		 113 113

    End points

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    End points reporting groups
    Reporting group title
    R-mini chop
    Reporting group description
    		 Standard Arm : All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D1) DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) *The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2

    Reporting group title
    R2-minichop
    Reporting group description
    		 Experimental Arm : All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) LENALIDOMIDE PO** (10 mg TD from D1 to D14)
    Reporting group title
    R-mini chop
    Reporting group description
    		 Standard Arm : All patients will be treated with R-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D1) DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) *The first cycle of rituximab is delivered by IV at the dose of 375 mg/m2

    Reporting group title
    R2-minichop
    Reporting group description
    		 Experimental Arm : All patients will be treated with R2-miniCHOP at a three-weeks interval for 6 cycles CYCLOPHOSPHAMIDE IV (400 mg/m² at D DOXORUBICINE IV (25 mg/m² at D1) VINCRISTINE IV (1 mg TD at D1) PREDNISONE PO (40 mg/m² from D1 to D5) RITUXIMAB SC* (1400 mg TD at D1) LENALIDOMIDE PO** (10 mg TD from D1 to D14)

    Primary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP ((Sub-cutaneous Rituximab-miniCHOP). OS will be measured from randomization to the date of death from any cause. Patients who withdraw consent for the study is considered censored at the time of withdrawal. Alive patients will be censored at their last contact.
    End point type
    Primary
    End point timeframe
    0, 6, 12, 24 .. every 6 months
    End point values
    		 R-mini chop R2-minichop
    Number of subjects analysed
    127
    122
    Units: Months
        median (inter-quartile range (Q1-Q3))
    43.5 (0.3 to 51.1)
    0 (0 to 48.5)
    Statistical analysis title
    		 Comparison of Overall survival
    Statistical analysis description
    Treatment with R2-miniCHOP will be declared superior if the one-sided p-value from unstratified log-rank test is < 0.05. Hazard ratio with two-sided 95% confidence intervals will be estimated using the Cox proportional hazards model if proportional hazard assumption holds. Graphical display of Kaplan-Meier curves will be provided to aid data interpretation visually
    Comparison groups
    R-mini chop v R2-minichop
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.98
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.996
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 1.509
    Notes
    [1] - A one-sided log-rank test will be used for testing the difference in overall survival between the two treatment groups. The significance level for the primary analysis will be 0.05. The hypothesis will be: H0: OS (R2-miniCHOP) = OS (R--miniCHOP) Versus HA: OS (R2-miniCHOP) ≥ OS (R-miniCHOP) Where OS denotes the survival distribution of the parameter time to overall survival. For secondary parameters, statistical tests will be two-sided and performed using a 5% level of significance

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of informed consent signature to 30 days after last drug administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    3
    Reporting groups
    Reporting group title
    R-miniChop
    Reporting group description
    		 Standard arm

    Reporting group title
    R2 minichop
    Reporting group description
    		 Experimental Arm

    Serious adverse events
    		 R-miniChop R2 minichop
    Total subjects affected by serious adverse events
         subjects affected / exposed
    76 / 124 (61.29%)
    54 / 117 (46.15%)
         number of deaths (all causes)
    42
    43
         number of deaths resulting from adverse events
    2
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
         subjects affected / exposed
    10 / 124 (8.06%)
    12 / 117 (10.26%)
         occurrences causally related to treatment / all
    3 / 11
    12 / 12
         deaths causally related to treatment / all
    1 / 2
    7 / 7
    Vascular disorders
    VASCULAR DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    3 / 117 (2.56%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Surgical and medical procedures
    SURGICAL AND MEDICAL PROCEDURES
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
         subjects affected / exposed
    6 / 124 (4.84%)
    8 / 117 (6.84%)
         occurrences causally related to treatment / all
    5 / 7
    8 / 9
         deaths causally related to treatment / all
    1 / 2
    1 / 1
    Reproductive system and breast disorders
    REPRODUCTIVE SYSTEM AND BREAST DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
         subjects affected / exposed
    4 / 124 (3.23%)
    13 / 117 (11.11%)
         occurrences causally related to treatment / all
    4 / 5
    16 / 18
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Psychiatric disorders
    PSYCHIATRIC DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    INJURY, POISONING AND PROCEDURAL COMPLICATIONS
         subjects affected / exposed
    3 / 124 (2.42%)
    7 / 117 (5.98%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    4 / 124 (3.23%)
    6 / 117 (5.13%)
         occurrences causally related to treatment / all
    3 / 4
    4 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    NERVOUS SYSTEM DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    3 / 117 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    BLOOD AND LYMPHATIC SYSTEM DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    6 / 117 (5.13%)
         occurrences causally related to treatment / all
    4 / 4
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    EYE DISORDERS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL DISORDERS
         subjects affected / exposed
    8 / 124 (6.45%)
    6 / 117 (5.13%)
         occurrences causally related to treatment / all
    2 / 11
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HEPATOBILIARY DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    SKIN AND SUBCUTANEOUS TISSUE DISORDERS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL AND URINARY DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    4 / 117 (3.42%)
         occurrences causally related to treatment / all
    0 / 4
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    ENDOCRINE DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    5 / 117 (4.27%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    INFECTIONS AND INFESTATIONS
         subjects affected / exposed
    12 / 124 (9.68%)
    17 / 117 (14.53%)
         occurrences causally related to treatment / all
    12 / 16
    20 / 21
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Metabolism and nutrition disorders
    METABOLISM AND NUTRITION DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    4 / 117 (3.42%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 R-miniChop R2 minichop
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 124 (70.16%)
    101 / 117 (86.32%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
         subjects affected / exposed
    10 / 124 (8.06%)
    12 / 117 (10.26%)
         occurrences all number
    11
    12
    Vascular disorders
    VASCULAR DISORDERS
         subjects affected / exposed
    3 / 124 (2.42%)
    7 / 117 (5.98%)
         occurrences all number
    3
    7
    Surgical and medical procedures
    SURGICAL AND MEDICAL PROCEDURES
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 117 (0.85%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
         subjects affected / exposed
    9 / 124 (7.26%)
    13 / 117 (11.11%)
         occurrences all number
    10
    15
    Reproductive system and breast disorders
    REPRODUCTIVE SYSTEM AND BREAST DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 117 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
         subjects affected / exposed
    8 / 124 (6.45%)
    16 / 117 (13.68%)
         occurrences all number
    11
    21
    Psychiatric disorders
    PSYCHIATRIC DISORDERS
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 117 (0.85%)
         occurrences all number
    2
    2
    Product issues
    PRODUCT ISSUES
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 117 (0.00%)
         occurrences all number
    1
    0
    Investigations
    INVESTIGATIONS
         subjects affected / exposed
    24 / 124 (19.35%)
    21 / 117 (17.95%)
         occurrences all number
    49
    67
    Injury, poisoning and procedural complications
    INJURY, POISONING AND PROCEDURAL COMPLICATIONS
         subjects affected / exposed
    5 / 124 (4.03%)
    10 / 117 (8.55%)
         occurrences all number
    5
    10
    Cardiac disorders
    CARDIAC DISORDERS
         subjects affected / exposed
    4 / 124 (3.23%)
    8 / 117 (6.84%)
         occurrences all number
    4
    9
    Nervous system disorders
    NERVOUS SYSTEM DISORDERS
         subjects affected / exposed
    7 / 124 (5.65%)
    7 / 117 (5.98%)
         occurrences all number
    7
    7
    Blood and lymphatic system disorders
    BLOOD AND LYMPHATIC SYSTEM DISORDERS
         subjects affected / exposed
    36 / 124 (29.03%)
    61 / 117 (52.14%)
         occurrences all number
    100
    147
    Eye disorders
    EYE DISORDERS
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 117 (0.85%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    GASTROINTESTINAL DISORDERS
         subjects affected / exposed
    9 / 124 (7.26%)
    10 / 117 (8.55%)
         occurrences all number
    12
    13
    Hepatobiliary disorders
    HEPATOBILIARY DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 117 (1.71%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    SKIN AND SUBCUTANEOUS TISSUE DISORDERS
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 117 (1.71%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    RENAL AND URINARY DISORDERS
         subjects affected / exposed
    3 / 124 (2.42%)
    6 / 117 (5.13%)
         occurrences all number
    5
    6
    Endocrine disorders
    ENDOCRINE DISORDERS
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 117 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
         subjects affected / exposed
    4 / 124 (3.23%)
    6 / 117 (5.13%)
         occurrences all number
    4
    6
    Infections and infestations
    INFECTIONS AND INFESTATIONS
         subjects affected / exposed
    40 / 124 (32.26%)
    35 / 117 (29.91%)
         occurrences all number
    56
    50
    Metabolism and nutrition disorders
    METABOLISM AND NUTRITION DISORDERSMETABOLISM AND NUTRITION DISORDERS
         subjects affected / exposed
    11 / 124 (8.87%)
    11 / 117 (9.40%)
         occurrences all number
    11
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jun 2014
    Actualization of SAE declarations rules.
    11 Dec 2015
    Precision regarding baseline examination, bone marrow aspirate was highly recommended to exclude underlying myelodysplasia and mandatory in case of unexplained cytopenia
    31 Oct 2016
    Precision to allow inclusion of patient with chronic Hepatitis B and specific surveillance of these patients to avoid risks of virus reactivation.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33444079
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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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