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    Clinical Trial Results:
    GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin’s lymphoma. A phase II study of the Fondazione Italiana Linfomi (FIL).

    Summary
    EudraCT number
    		 2014-005697-10
    Trial protocol
    		 IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2022
    First version publication date
    22 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FIL_GAEL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fondazione Italiana Linfomi
    Sponsor organisation address
    Piazza Turati 5, Alessandria , Italy,
    Public contact
    Segreteria FIL ONLUS, Fondazione Italiana Linfomi ONLUS, 0039 0131206288, segreteria@filinf.it
    Scientific contact
    Segreteria FIL ONLUS, Fondazione Italiana Linfomi ONLUS, 0039 0131206288, segreteria@filinf.it
    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
    Interim
    Date of interim/final analysis
    22 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the activity of GA101-miniCHOP regimen in terms of complete response rate (CRR)
    Protection of trial subjects
    Analysis of safety information from clinical studies were crucial for the protection of subjects. The responsible investigator ensured that this study was conducted in agreement with either the Declaration of Helsinki or the laws and regulations of the country, whichever provides the greatest protection of the patient.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 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)
    0
    From 65 to 84 years
    26
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 Older adults (≥65 years) with a newly diagnosed DLBCL were considered eligible if they were unfit on the sCGA (comprehensive geriatric assessment).

    Pre-assignment
    Screening details
    		 1) Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade IIIB; 2) Age ≥ 65 years; 3) No previous treatment; 4) CGA assessment performed before starting treatment; 5) UNFIT patients; 6) AA Stage I with bulky, II-IV; 7) measurable lesion defined as > 1.5 cm; 8)ECOGPS <3; 9)written informent consent.

    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
    		 Single Arm Study
    Arm description
    		 Treatment plan consisted of six cycles of Ga101 (obinutuzumab) -miniCHOP followed by two additional doses of Ga101, every 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg/mq, day 1, iv

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/mq, day 1, iv

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg, day 1, iv

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/mq, days 1-5, os

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg day 1, iv, every 21 days

    Number of subjects in period 1
    		Single Arm Study
    Started
    33
    Completed
    33

    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
    		 33 33
    Age categorical
    Units: Subjects
        From 65-84 years
    		 26 26
        85 years and over
    		 7 7
    Age continuous
    Units: years
        median (full range (min-max))
    		 82 (68 to 89) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 18 18
    Stage
    Units: Subjects
        Stage I-II
    		 6 6
        Stage III-IV
    		 27 27
    Lactate Dehydrogenase
    Units: Subjects
        LDH <=ULN
    		 10 10
        LDH >ULN
    		 23 23
    ECOG-PS
    Units: Subjects
        PS 0-1
    		 31 31
        PS 2
    		 1 1
        PS 3
    		 1 1
    International Prognostic Index
    Units: Subjects
        IPI 1-2
    		 12 12
        IPI 3/5
    		 21 21
    sCGA
    Semplified Comprehensive Geriatric Assessement
    Units: Subjects
        UNFIT
    		 28 28
        FRAIL
    		 5 5
    Hemoglobin
    Units: g/dL
        median (full range (min-max))
    		 12.9 (8.9 to 15.7) -
    ALC
    Absolute Lymphocyte Count
    Units: 10^9/L
        median (full range (min-max))
    		 1.2 (0.2 to 3.5) -
    Subject analysis sets

    Subject analysis set title
    Subject analyzed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    From August 2015 to June 2016, 34 patients were enrolled by sixteen Italian centers: one patient was subsequently excluded due to violation of inclusion criteria (Richter syndrome)

    Subject analysis sets values
    		 Subject analyzed
    Number of subjects
    33
    Age categorical
    Units: Subjects
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    18
    Stage
    Units: Subjects
        Stage I-II
    6
        Stage III-IV
    27
    Lactate Dehydrogenase
    Units: Subjects
        LDH <=ULN
    10
        LDH >ULN
    23
    ECOG-PS
    Units: Subjects
        PS 0-1
    31
        PS 2
    1
        PS 3
    1
    International Prognostic Index
    Units: Subjects
        IPI 1-2
    12
        IPI 3/5
    21
    sCGA
    Semplified Comprehensive Geriatric Assessement
    Units: Subjects
        UNFIT
    28
        FRAIL
    5
    Hemoglobin
    Units: g/dL
        median (full range (min-max))
    12.9 (8.9 to 15.7)
    ALC
    Absolute Lymphocyte Count
    Units: 10^9/L
        median (full range (min-max))

    End points

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    End points reporting groups
    Reporting group title
    Single Arm Study
    Reporting group description
    		 Treatment plan consisted of six cycles of Ga101 (obinutuzumab) -miniCHOP followed by two additional doses of Ga101, every 21 days.

    Subject analysis set title
    Subject analyzed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    From August 2015 to June 2016, 34 patients were enrolled by sixteen Italian centers: one patient was subsequently excluded due to violation of inclusion criteria (Richter syndrome)

    Primary: Response Rate

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    End point title
    		 Response Rate
    End point description
    Maximum response attained, according Cheson 1999. Complete remission (CR), partial remission (PR), stable disease (SD), progression disease (PD), not assessed (NA)
    End point type
    Primary
    End point timeframe
    8 months from registration
    End point values
    		 Single Arm Study Subject analyzed
    Number of subjects analysed
    33
    33
    Units: number of patients
        CR
    14
    14
        PR
    8
    8
        SD
    2
    2
        PD
    8
    8
        NA
    1
    1
    Statistical analysis title
    		 Rate of complete response
    Statistical analysis description
    Percent frequency
    Comparison groups
    Single Arm Study v Subject analyzed
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Frequency percent (%)
    Point estimate
    42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25
         upper limit
    		 61

    Secondary: Overall Response (ORR)

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    End point title
    		 Overall Response (ORR)
    End point description
    End point type
    Secondary
    End point timeframe
    Complete and partial response according to Cheson 1999
    End point values
    		 Single Arm Study Subject analyzed
    Number of subjects analysed
    33
    33
    Units: number of patients
        ORR
    22
    22
        Less than ORR
    11
    11
    Statistical analysis title
    		 Overall Response Rate
    Comparison groups
    Single Arm Study v Subject analyzed
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Frequency percent (%)
    Point estimate
    67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 48
         upper limit
    		 82
    Notes
    [1] - Frequency of overall response rate (ORR)

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    From the date of regsitration in the trial to the date of death for any causes or last clinical contact.
    End point type
    Secondary
    End point timeframe
    60 months
    End point values
    		 Single Arm Study Subject analyzed
    Number of subjects analysed
    33
    33
    Units: Probability of survival at 2-years
        number (confidence interval 68%)
    68 (49 to 81)
    68 (49 to 81)
    Statistical analysis title
    		 Overall Survival
    Comparison groups
    Single Arm Study v Subject analyzed
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 2- years OS
    Point estimate
    68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49
         upper limit
    		 81

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    From the date of registration to the date of prpgression or death for any causes or date of last clinical contact (censored cases).
    End point type
    Secondary
    End point timeframe
    60 months
    End point values
    		 Single Arm Study Subject analyzed
    Number of subjects analysed
    33
    33
    Units: Probability at 2-years
        number (confidence interval 49%)
    49 (28 to 67)
    49 (28 to 67)
    Statistical analysis title
    		 Progression Free Survival
    Comparison groups
    Single Arm Study v Subject analyzed
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 2-year probability
    Point estimate
    49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28
         upper limit
    		 67

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    60 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Single arm study
    Reporting group description
    		 -

    Serious adverse events
    		 Single arm study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 33 (18.18%)
         number of deaths (all causes)
    10
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Congestive heart failure
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Obstructive chronic bronchopneumopathy
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar pain, vertbral collapse
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    fever, sepsis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Single arm study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 33 (84.85%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Vascular disorders
    Vascular disorder
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    General disorders and administration site conditions
    General disorder
         subjects affected / exposed
    9 / 33 (27.27%)
         occurrences all number
    9
    Investigations
    Investigations
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Procedural complication
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    7 / 33 (21.21%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    6 / 33 (18.18%)
         occurrences all number
    6
    Leukopenia
         subjects affected / exposed
    4 / 33 (12.12%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    15 / 33 (45.45%)
         occurrences all number
    15
    Thrombocytopenia
         subjects affected / exposed
    11 / 33 (33.33%)
         occurrences all number
    11
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    13 / 33 (39.39%)
         occurrences all number
    13
    Hepatobiliary disorders
    Hepatobiliary disorder
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal disorder
         subjects affected / exposed
    8 / 33 (24.24%)
         occurrences all number
    8
    Infections and infestations
    Infections
         subjects affected / exposed
    10 / 33 (30.30%)
         occurrences all number
    10
    Metabolism and nutrition disorders
    Metabolism disorder
         subjects affected / exposed
    8 / 33 (24.24%)
         occurrences all number
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    28 Feb 2017
    The study was early interrupted at the interim analysis becouse the complete remission rate less than expected. Enrolled 33 patients in place of 78 planned patients.
    -

    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
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