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    Clinical Trial Results:
    Therapy of Nodal Follicular Non-Hodgkin Lymphoma (WHO grade 1/2) in Clinical Stage I/II using Response Adapted Involved Site Radiotherapy in Combination with Gazyvaro

    Summary
    EudraCT number
    		 2016-002059-89
    Trial protocol
    		 DE  
    Global end of trial date
    14 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 May 2026
    First version publication date
    03 May 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GAZAI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03341520
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Heidelberg
    Sponsor organisation address
    Im Neuenheimer Feld 672, Heidelberg, Germany, 69120
    Public contact
    Prof. Dr. med. Klaus Herfarth, Abteilung Radioonkologie & Strahlentherapie, Universitätsklinikum Heidelberg, 0049 622156 8202, Klaus.Herfarth@med.uni-heidelberg.de
    Scientific contact
    Prof. Dr. med. Klaus Herfarth, Abteilung Radioonkologie & Strahlentherapie, Universitätsklinikum Heidelberg, 0049 622156 8202, Klaus.Herfarth@med.uni-heidelberg.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
    28 Jul 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The rate of metabolic CR after low-dose radiotherapy in combination with Gazyvaro (Obinutuzumab) for early stage nodal follicular lymphoma was assessed. In addition, the feasibility of a response adapted approach using FDG-PET/CT regarding success (PFS, rates of remission, analysis of recurrences) and safety in combination with Gazyvaro were assessed. The results were historically compared to the results of the MIR trial regarding morphologic response in week 7 and the quality of life (secondary endpoints). Additional secondary endpoints were PFS, the site of recurrences in the three subgroups (1. PET negative after initial staging; 2. PET negative in week 18; 3. PET positive in week 18). Primary Evaluation of the rate of metabolic CR after low-dose involved site radiotherapy in combination with Gazyvaro (Obinutuzumab) in early stage nodal follicular lymphoma in order to avoid conventional full dose IF radiotherapy.
    Protection of trial subjects
    Monitoring of all patients for occurrence of adverse events including lab results
    Background therapy
    		 Salvage radiotherapy if there is no metabolical CR and morphological PR/CR/CRu at week 18: additional 18 x 2 Gy (5x2 Gy/week) starting from week 20 (without Obinutuzumab) Dosing according to ICRU 50
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2017
    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: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    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)
    67
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 89 patients were recruited. Eleven patients were excluded due to different stage after PET scan (n=7) , different histology after central pathology review (n=2), extra-nodal disease (n=1) and start of a different therapy (n=1).

    Pre-assignment
    Screening details
    		 There was a two stage screening: a) Histology and CT or MRI: centrally approved follicular lymphoma grade 1/2 in clinical stage I/II (max. 93 patients) b) FDG-PET/CT: exclusion of stage III/IV patients (approx.. 15%= 14 patients) Inclusion of max 79 patients: ca. 70% (=55 patients with remaining lymphoma)

    Period 1
    Period 1 title
    Screening
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a single-arm study.

    Arms
    Arm title
    		 Screening (no intervention yet)
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Screening (no intervention yet)
    Started
    89
    Treatment started
    89
    Completed
    78
    Not completed
    11
         different histology after central review
    2
         extranodal disease
    1
         start of different therapy
    1
         different stage after PET scan
    7
    Period 2
    Period 2 title
    Full analysis set
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding (single arm study)

    Arms
    Arm title
    		 Obinutuzumab treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    L01XC15
    Other name
    Gazyvaro
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cycle 1, Day 1 (1000 mg): Administer at 50 mg/hr. The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr. Cycles 2-7: Day 1 (1000 mg). If there were no infusion related side effects during previous administrations, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 is the screening period. Data regarding age and sex distribution were only available for the full analysis set (period 2)
    Number of subjects in period 2 [2]
    		Obinutuzumab treatment
    Started
    78
    Completed
    78
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Period 1 is the screening period. Data regarding age and sex distribution were only available for the full analysis set (period 2)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full analysis set
    Reporting group description
    		 -

    Reporting group values
    		 Full analysis set Total
    Number of subjects
    		 78 78
    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)
    		 59 59
        From 65-84 years
    		 19 19
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57.0 (23.0 to 77.0) -
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 37 37
    Subject analysis sets

    Subject analysis set title
    Lymphoma set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The lymphoma set (LS) comprises all patients with initially remaining PET positive lymphoma and consists of 54 patients.

    Subject analysis sets values
    		 Lymphoma set
    Number of subjects
    54
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    40
        From 65-84 years
    14
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    58 (31 to 77)
    Gender categorical
    Units: Subjects
        Female
    28
        Male
    26

    End points

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    End points reporting groups
    Reporting group title
    Screening (no intervention yet)
    Reporting group description
    		 -
    Reporting group title
    Obinutuzumab treatment
    Reporting group description
    		 -

    Subject analysis set title
    Lymphoma set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The lymphoma set (LS) comprises all patients with initially remaining PET positive lymphoma and consists of 54 patients.

    Primary: Metabolic complete response ( in week 18 in patients with initially remaining lymphoma judged by FDG PET/CT)

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    End point title
    		 Metabolic complete response ( in week 18 in patients with initially remaining lymphoma judged by FDG PET/CT) [1]
    End point description
    Evaluation of the rate of metabolic CR after low dose involved site radiotherapy in combination with Gazyvaro (in early stage nodal follicular lymphoma in order to avoid conventional full dose IF radiotherapy).
    End point type
    Primary
    End point timeframe
    week 18
    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 control arm
    End point values
    		 Lymphoma set
    Number of subjects analysed
    Units: number of patients
    53
    Attachments
    		 Complete Remission
    No statistical analyses for this end point

    Secondary: Morphologic CR, PR, SD, PD in patients with initially remaining lymphoma judged by CT/MRI, week 7

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    End point title
    		 Morphologic CR, PR, SD, PD in patients with initially remaining lymphoma judged by CT/MRI, week 7
    End point description
    End point type
    Secondary
    End point timeframe
    week 7
    End point values
    		 Lymphoma set
    Number of subjects analysed
    54
    Units: number of patients
        Complete Remission
    21
        Partial Remission
    18
        Stable Disease
    15
        Progressive Disease
    0
    No statistical analyses for this end point

    Secondary: Morphologic CR, PR, SD, PD in patients with initially remaining lymphoma judged by CT/MRI, Week 18

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    End point title
    		 Morphologic CR, PR, SD, PD in patients with initially remaining lymphoma judged by CT/MRI, Week 18
    End point description
    End point type
    Secondary
    End point timeframe
    week 18
    End point values
    		 Lymphoma set
    Number of subjects analysed
    54
    Units: number of patients
        Complete Remission
    49
        Partial Remission
    4
        Stable Disease
    0
        Progressive Disease
    1
    No statistical analyses for this end point

    Secondary: Progression free survival: two-year survival rate

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    End point title
    		 Progression free survival: two-year survival rate
    End point description
    End point type
    Secondary
    End point timeframe
    2 years after individual treatment start
    End point values
    		 Lymphoma set
    Number of subjects analysed
    54
    Units: survival rate
    48
    No statistical analyses for this end point

    Secondary: Overall survival: two-year survival rate

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    End point title
    		 Overall survival: two-year survival rate
    End point description
    End point type
    Secondary
    End point timeframe
    2 year survival following individual treatment start
    End point values
    		 Obinutuzumab treatment
    Number of subjects analysed
    78
    Units: survival rate
    76
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The observation period begins with the first administration of the Gazyvaro (before the first administration of the Gazyvaro: medical history) and ends with the last study visit, i.e. 30 month after the last take of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27
    Reporting groups
    Reporting group title
    Full analysis set
    Reporting group description
    		 -

    Serious adverse events
    		 Full analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 78 (11.54%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Investigations
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Lithotripsy
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Focal dyscognitive seizures
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Middle lobe syndrome
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Ureteric obstruction
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Full analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 78 (83.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    6
    Vascular disorders, all other AEs from this SOC
         subjects affected / exposed
    8 / 78 (10.26%)
         occurrences all number
    8
    Surgical and medical procedures
    Surgical and medical procedures, all AEs from this SOC
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    5
    General disorders and administration site conditions
    Eye disorders, all AEs fron this SOC
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    Fatigue
         subjects affected / exposed
    23 / 78 (29.49%)
         occurrences all number
    25
    Pyrexia
         subjects affected / exposed
    15 / 78 (19.23%)
         occurrences all number
    15
    Chills
         subjects affected / exposed
    6 / 78 (7.69%)
         occurrences all number
    7
    General disorders and administration site conditions, all other AEs from this SOC
         subjects affected / exposed
    13 / 78 (16.67%)
         occurrences all number
    15
    Immune system disorders
    Immune system disorders, all AEs from this SOC
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    5
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders, all other AEs from this SOC
         subjects affected / exposed
    20 / 78 (25.64%)
         occurrences all number
    22
    Psychiatric disorders
    Psychiatric disorders, all AEs from this SOC
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences all number
    7
    Investigations
    Investigations, all AEs from this SOC
         subjects affected / exposed
    18 / 78 (23.08%)
         occurrences all number
    18
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    11 / 78 (14.10%)
         occurrences all number
    13
    Rib fracture
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    4
    Injury, poisoning and procedural complications, all other AEs from this SOC
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences all number
    8
    Cardiac disorders
    Cardiac disorders, all AEs from this SOC
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 78 (12.82%)
         occurrences all number
    11
    Nervous system disorders, all other AEs from this SOC
         subjects affected / exposed
    21 / 78 (26.92%)
         occurrences all number
    21
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders, all AEs from this SOC
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences all number
    12
    Ear and labyrinth disorders
    Block vertebra
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences all number
    1
    Ear and labyrith disorder, all AEs from this SOC
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    9 / 78 (11.54%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    10 / 78 (12.82%)
         occurrences all number
    15
    Gastrointestinal disorders, all other AEs from this SOC
         subjects affected / exposed
    20 / 78 (25.64%)
         occurrences all number
    21
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    6
    Pruritus
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders, all other AEs from this SOC
         subjects affected / exposed
    19 / 78 (24.36%)
         occurrences all number
    19
    Renal and urinary disorders
    Renal and urinary disorders, all AEs from this SOC
         subjects affected / exposed
    5 / 78 (6.41%)
         occurrences all number
    5
    Endocrine disorders
    Endocrine disorders, all AEs from this SOC
         subjects affected / exposed
    2 / 78 (2.56%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 78 (8.97%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    3 / 78 (3.85%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders, all other AEs from this SOC
         subjects affected / exposed
    29 / 78 (37.18%)
         occurrences all number
    30
    Infections and infestations
    COVID-19
         subjects affected / exposed
    14 / 78 (17.95%)
         occurrences all number
    15
    Urinary tract infection
         subjects affected / exposed
    4 / 78 (5.13%)
         occurrences all number
    6
    Nasopharyngitis
         subjects affected / exposed
    6 / 78 (7.69%)
         occurrences all number
    7
    Infections and infestations, all other AEs from this SOC
         subjects affected / exposed
    31 / 78 (39.74%)
         occurrences all number
    33
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders, all AEs from this SOC
         subjects affected / exposed
    9 / 78 (11.54%)
         occurrences all number
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jun 2018
    Protocol: adjustment of in --/exclusion criterias (laboratory values); addition of pregnancy test in the follow up phase; regulatory adjustments (adjustme nt of known side effects
    06 Jul 2018
    Implementation of notes from the EC
    02 Jan 2019
    Protocol: New member of the data monitoring committee; adjustment of milestones; adjustment of second assessor; regulatory adjustments

    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
    For support, Contact us.
    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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