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    Clinical Trial Results:
    Phase II Study of Fractionated 90Y Ibritumomab tiuxetan (ZevalinTM) as initial therapy of Follicular Lymphoma

    Summary
    EudraCT number
    		 2006-000598-31
    Trial protocol
    		 GB  
    Global end of trial date
    06 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2020
    First version publication date
    07 Mar 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    06_DOG05_33
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01493479
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Christie NHS Foundation Trust
    Sponsor organisation address
    Wilmslow Road, Manchester, United Kingdom, M20 4BX
    Public contact
    The Christie NHS Foundation Trust, The Christie NHS Foundation Trust, christiesponsoredresearch@christie.nhs.uk
    Scientific contact
    The Christie NHS Foundation Trust, The Christie NHS Foundation Trust, christiesponsoredresearch@christie.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jan 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this project is to test the safety and efficacy of two fractions of 90Y ibritumomab tiuxetan in patients with previously untreated follicular lymphoma in a Phase II study.
    Protection of trial subjects
    Rituximab is given by intravenous infusion on day 1 and day 8, which can take up to a few hours to complete. 90-Y-ibritumomab tiuxetan (ZevalinTM) is also given by intravenous infusion which takes approximately 10 minutes on day 8. Both these drugs may cause flu-like symptoms and other side effects as listed in the patient information sheet. Patients are advised
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 41
    Country: Number of subjects enrolled
    France: 31
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    45
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening and baseline evaluations performed within 3 weeks of study entry included - ECG, US echo or left VEF , CT scan, PET scan if patients are eligible for treatment with Zevalin, HAMA and HACA reactivity analysis, Bone marrow biopsy for cytology, pathology, immuno-phenotyping (CD20 staining) and percentage of involvement (must be ≤20%)

    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
    Arm description
    		 The FIZZ trial investigated the use of 90Y Ibritumomab tiuxetan (Zevalin), as an initial treatment for previously untreated follicular lymphoma. This is a single arm, open-label trial; patients receive 2 infusions of 90Y Ibritumomab tiuxetan (ZevalinTM), (11.1 MBq/kg) given 8-12 weeks apart. Each treatment is preceded by 2 infusions of rituximab 7-8 days apart. Patients with >20% bone marrow involvement also receive 4 x weekly rituximab infusions prior to entering the main trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Zevalin
    Investigational medicinal product code
    Other name
    90Y Ibritumomab tiuxetan
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    90Y-ibritumomab tiuxetan (Zevalin) is composed of a murine IgG1 monoclonal antibody (ibritumomab) covalently bound to the chelating agent tiuxetan. The antibody is chelated with the ß-emitter yttrium-90 chloride immediately before intravenous administration to prepare [90Y] Zevalin, the active therapeutic agent. 90Y-ibritumomab tiuxetan (11.1 MBq/kg) treatment is preceded by two infusions of 250 mg/m2 Rituximab given 7-8 days apart with the second infusion given immediately prior to [90Y] Zevalin. Rituximab is a chimeric human/murine IgG1 monoclonal antibody. Two treatments of 90Y-ibritumomab tiuxetan (11.1 MBq/kg) are given 8-12 weeks apart. In patients with greater than 20% bone marrow involvement with lymphoma, Rituximab (375 mg/m2) is administered as 4 weekly infusions. Following a repeat bone marrow biopsy, patients with less than or equal to 20% involvement will follow the protocol in the previous paragraph.

    Number of subjects in period 1
    		Single arm
    Started
    72
    Completed
    72

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 The FIZZ trial investigated the use of 90Y Ibritumomab tiuxetan (Zevalin), as an initial treatment for previously untreated follicular lymphoma. This is a single arm, open-label trial; patients receive 2 infusions of 90Y Ibritumomab tiuxetan (ZevalinTM), (11.1 MBq/kg) given 8-12 weeks apart. Each treatment is preceded by 2 infusions of rituximab 7-8 days apart. Patients with >20% bone marrow involvement also receive 4 x weekly rituximab infusions prior to entering the main trial.

    Reporting group values
    		 Single arm Total
    Number of subjects
    		 72 72
    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)
    		 45 45
        From 65-84 years
    		 27 27
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 61 (28 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 33 33

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 The FIZZ trial investigated the use of 90Y Ibritumomab tiuxetan (Zevalin), as an initial treatment for previously untreated follicular lymphoma. This is a single arm, open-label trial; patients receive 2 infusions of 90Y Ibritumomab tiuxetan (ZevalinTM), (11.1 MBq/kg) given 8-12 weeks apart. Each treatment is preceded by 2 infusions of rituximab 7-8 days apart. Patients with >20% bone marrow involvement also receive 4 x weekly rituximab infusions prior to entering the main trial.

    Subject analysis set title
    Zevalin
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All 72 subjects receiving at least one dose of Zevalin

    Primary: Overall response rate (ORR)

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    End point title
    		 Overall response rate (ORR) [1]
    End point description
    End point type
    Primary
    End point timeframe
    initial primary end point evaluation. From baseline to 3 months post treatment.
    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: Single arm study. ORR: 68 out of 72; 94.4% with 95% CI (86.4%, 98.5%)
    End point values
    		 Single arm
    Number of subjects analysed
    72
    Units: Number of patients
    68
    No statistical analyses for this end point

    Primary: Combined Complete Response (CR/CRu)

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    End point title
    		 Combined Complete Response (CR/CRu) [2]
    End point description
    End point type
    Primary
    End point timeframe
    initial primary end point evaluation. From baseline to 3 months post treatment.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Single arm study. CR/CRu: 42 out of 72; 58.3% with 95% CI (46.1%, 69.8%)
    End point values
    		 Single arm
    Number of subjects analysed
    72
    Units: Number of patients
    42
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Zevalin
    Reporting group description
    		 -

    Serious adverse events
    		 Zevalin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 72 (23.61%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
    Additional description: BASAL CELL CARCINOMA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PLEURAL CARCINOMA
    Additional description: PLEURAL CARCINOMA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    SIGMOID COLON CANCER
    Additional description: SIGMOID COLON CANCER
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    NEUTROPENIA
    Additional description: NEUTROPENIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    FRACTURE
    Additional description: FRACTURE
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    ACUTE MYELOBLASTIC LEUKEMIA
    Additional description: ACUTE MYELOBLASTIC LEUKEMIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    FEBRILE NEUTROPENIA
    Additional description: FEBRILE NEUTROPENIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MYELODYSPLASIA
    Additional description: MYELODYSPLASIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MYELODYSPLASIA (RCMD)
    Additional description: MYELODYSPLASIA (RCMD)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    FEVER
    Additional description: FEVER
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    PAIN
    Additional description: PAIN
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    BREAST CANCER
    Additional description: BREAST CANCER
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
    Additional description: DYSPNOEA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HAEMOPTYSIS
    Additional description: HAEMOPTYSIS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    CELLULITIS
    Additional description: CELLULITIS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    PSYCHOSIS
    Additional description: PSYCHOSIS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    1 / 72 (1.39%)
         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
    		 Zevalin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 72 (84.72%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CYST (EPIDIDYMIS)
    Additional description: CYST (EPIDIDYMIS)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    NODULE (LEFT AXILLA)
    Additional description: NODULE (LEFT AXILLA)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    SMALL SKIN LESION ON LEFT SIDE - POSSIBLE BCC
    Additional description: SMALL SKIN LESION ON LEFT SIDE - POSSIBLE BCC
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Surgical and medical procedures
    RIGHT INGUINAL HERNIA REPAIR
    Additional description: RIGHT INGUINAL HERNIA REPAIR
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    General disorders and administration site conditions
    FEELING SHAKEN (RTA)
    Additional description: FEELING SHAKEN (RTA)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    FEELING SHAKY
    Additional description: FEELING SHAKY
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    FEELING UNWELL
    Additional description: FEELING UNWELL
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    FEVER
    Additional description: FEVER
         subjects affected / exposed
    12 / 72 (16.67%)
         occurrences all number
    13
    HEADACHE
    Additional description: HEADACHE
         subjects affected / exposed
    10 / 72 (13.89%)
         occurrences all number
    12
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    13 / 72 (18.06%)
         occurrences all number
    17
    INFUSION REACTION (RITUXIMAB)
    Additional description: INFUSION REACTION (RITUXIMAB)
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    3
    LETHARGY
    Additional description: LETHARGY
         subjects affected / exposed
    28 / 72 (38.89%)
         occurrences all number
    39
    OEDEMA
    Additional description: OEDEMA
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    PAIN
    Additional description: PAIN
         subjects affected / exposed
    7 / 72 (9.72%)
         occurrences all number
    10
    Reproductive system and breast disorders
    AMENORRHEA
    Additional description: AMENORRHEA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    IRREGULAR MENSES
    Additional description: IRREGULAR MENSES
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    AIRWAY OBSTRUCTION
    Additional description: AIRWAY OBSTRUCTION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    ALLERGIC REACTION
    Additional description: ALLERGIC REACTION
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences all number
    4
    CATARRH
    Additional description: CATARRH
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    CORYZAL SYMPTOMS
    Additional description: CORYZAL SYMPTOMS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    COUGH
    Additional description: COUGH
         subjects affected / exposed
    12 / 72 (16.67%)
         occurrences all number
    12
    DRY THROAT
    Additional description: DRY THROAT
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    DYSPNOEA
    Additional description: DYSPNOEA
         subjects affected / exposed
    6 / 72 (8.33%)
         occurrences all number
    7
    EPISTAXIS (NOSE)
    Additional description: EPISTAXIS (NOSE)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    15 / 72 (20.83%)
         occurrences all number
    19
    REDUCED CHEST EXPANSION
    Additional description: REDUCED CHEST EXPANSION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    SORE THROAT
    Additional description: SORE THROAT
         subjects affected / exposed
    9 / 72 (12.50%)
         occurrences all number
    11
    TIGHTNESS CHEST
    Additional description: TIGHTNESS CHEST
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Psychiatric disorders
    ANXIETY
    Additional description: ANXIETY
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences all number
    5
    DEPRESSION
    Additional description: DEPRESSION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    INSOMNIA
    Additional description: INSOMNIA
         subjects affected / exposed
    6 / 72 (8.33%)
         occurrences all number
    6
    Investigations
    HYPERCHOLESTEROLAEMIA
    Additional description: HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    HYPOKALAEMIA
    Additional description: HYPOKALAEMIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    LYMPHOPENIA
    Additional description: LYMPHOPENIA
         subjects affected / exposed
    8 / 72 (11.11%)
         occurrences all number
    10
    NEUTROPENIA
    Additional description: NEUTROPENIA
         subjects affected / exposed
    22 / 72 (30.56%)
         occurrences all number
    54
    RAISED ALANINE TRANSAMINASE
    Additional description: RAISED ALANINE TRANSAMINASE
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    THROMBOCYTOPAENIA
    Additional description: THROMBOCYTOPAENIA
         subjects affected / exposed
    37 / 72 (51.39%)
         occurrences all number
    83
    Injury, poisoning and procedural complications
    ANKLE FRACTURE
    Additional description: ANKLE FRACTURE
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    BRUISING
    Additional description: BRUISING
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences all number
    7
    Cardiac disorders
    BRADYCARDIA SINUS
    Additional description: BRADYCARDIA SINUS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    CARDIAC ARRHYTHMIAS (PREMATURE ECTOPIES)
    Additional description: CARDIAC ARRHYTHMIAS (PREMATURE ECTOPIES)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    HYPERTENSION
    Additional description: HYPERTENSION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    2
    HYPOTENSION
    Additional description: HYPOTENSION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    LIGHTHEADEDNESS
    Additional description: LIGHTHEADEDNESS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    TACHYCARDIA
    Additional description: TACHYCARDIA
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Nervous system disorders
    DIZZINESS
    Additional description: DIZZINESS
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences all number
    4
    DYSGEUSIA
    Additional description: DYSGEUSIA
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    LETHARGY
    Additional description: LETHARGY
         subjects affected / exposed
    7 / 72 (9.72%)
         occurrences all number
    8
    MOTOR SENSORY IMPAIRMENT (LEFT TEMPORAL + PERINEAL)
    Additional description: MOTOR SENSORY IMPAIRMENT (LEFT TEMPORAL + PERINEAL)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    PINS AND NEEDLES (LEFT LOWER ARM)
    Additional description: PINS AND NEEDLES (LEFT LOWER ARM)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    PTOSIS (LEFT EYE)
    Additional description: PTOSIS (LEFT EYE)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    TREMOR (HANDS)
    Additional description: TREMOR (HANDS)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    ANAEMIA
    Additional description: ANAEMIA
         subjects affected / exposed
    20 / 72 (27.78%)
         occurrences all number
    36
    DERANGED BLOOD COUNTS
    Additional description: DERANGED BLOOD COUNTS
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    HAEMORRHAGE (GUMS)
    Additional description: HAEMORRHAGE (GUMS)
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    JUGULAR VEIN THROMBOSIS
    Additional description: JUGULAR VEIN THROMBOSIS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    LEUCOPENIA
    Additional description: LEUCOPENIA
         subjects affected / exposed
    23 / 72 (31.94%)
         occurrences all number
    50
    MYELOSUPPRESSION
    Additional description: MYELOSUPPRESSION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    PETECHIA (LOWER LIMBS )
    Additional description: PETECHIA (LOWER LIMBS )
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    VERTIGO DUE TO ANAEMIA SYNDROME
    Additional description: VERTIGO DUE TO ANAEMIA SYNDROME
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Ear and labyrinth disorders
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    OTORRHAGIA
    Additional description: OTORRHAGIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    REDUCED HEARING
    Additional description: REDUCED HEARING
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Eye disorders
    CATARACT (LEFT EYE)
    Additional description: CATARACT (LEFT EYE)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    DIPLOPIA (LEFT EYE)
    Additional description: DIPLOPIA (LEFT EYE)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    DRY EYES
    Additional description: DRY EYES
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    DRYNESS
    Additional description: DRYNESS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Gastrointestinal disorders
    ANOREXIA
    Additional description: ANOREXIA
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences all number
    5
    BLOATING
    Additional description: BLOATING
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    CONSTIPATION
    Additional description: CONSTIPATION
         subjects affected / exposed
    8 / 72 (11.11%)
         occurrences all number
    9
    DIARRHOEA
    Additional description: DIARRHOEA
         subjects affected / exposed
    9 / 72 (12.50%)
         occurrences all number
    10
    DRY MOUTH
    Additional description: DRY MOUTH
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    DYSPEPSIA
    Additional description: DYSPEPSIA
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    DYSPHAGIA
    Additional description: DYSPHAGIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    2
    FLATULENCE
    Additional description: FLATULENCE
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    FLEXIBLE AND DEPRESSIBLE ABDOMINAL
    Additional description: FLEXIBLE AND DEPRESSIBLE ABDOMINAL
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    FULLNESS (LEFT GROIN)
    Additional description: FULLNESS (LEFT GROIN)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    INDIGESTION
    Additional description: INDIGESTION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    3
    MUCOSITIS
    Additional description: MUCOSITIS
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences all number
    6
    NAUSEA
    Additional description: NAUSEA
         subjects affected / exposed
    18 / 72 (25.00%)
         occurrences all number
    21
    PYROSIS
    Additional description: PYROSIS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    RECTAL BLEEDING
    Additional description: RECTAL BLEEDING
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    TOOTH PAIN
    Additional description: TOOTH PAIN
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    VOMITING
    Additional description: VOMITING
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    BALANTIS XEROTICA OBLITERANS
    Additional description: BALANTIS XEROTICA OBLITERANS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    BLISTERED HAND
    Additional description: BLISTERED HAND
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    COLD SORES
    Additional description: COLD SORES
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    3
    DESQUAMATION
    Additional description: DESQUAMATION
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    DRY SKIN
    Additional description: DRY SKIN
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences all number
    5
    ECZEMA
    Additional description: ECZEMA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    PALLID
    Additional description: PALLID
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    PRURITIS
    Additional description: PRURITIS
         subjects affected / exposed
    11 / 72 (15.28%)
         occurrences all number
    13
    RASH
    Additional description: RASH
         subjects affected / exposed
    15 / 72 (20.83%)
         occurrences all number
    17
    RESIDUAL BRUSIE + ULCERATED SKIN (RIGHT FOOT)
    Additional description: RESIDUAL BRUSIE + ULCERATED SKIN (RIGHT FOOT)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    SENSITIVE SKIN
    Additional description: SENSITIVE SKIN
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    Additional description: ARTHRALGIA
         subjects affected / exposed
    5 / 72 (6.94%)
         occurrences all number
    5
    DISCOMFORT (LEFT CALF)
    Additional description: DISCOMFORT (LEFT CALF)
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    GOUT
    Additional description: GOUT
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    MUSCLE WEAKNESS
    Additional description: MUSCLE WEAKNESS
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    MYALGIA
    Additional description: MYALGIA
         subjects affected / exposed
    10 / 72 (13.89%)
         occurrences all number
    13
    PAIN
    Additional description: PAIN
         subjects affected / exposed
    17 / 72 (23.61%)
         occurrences all number
    27
    SCIATICA
    Additional description: SCIATICA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    SWELLING
    Additional description: SWELLING
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences all number
    3
    Infections and infestations
    INFECTION
    Additional description: INFECTION
         subjects affected / exposed
    10 / 72 (13.89%)
         occurrences all number
    12
    Metabolism and nutrition disorders
    HYPOCALCEMIA
    Additional description: HYPOCALCEMIA
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 May 2007
    Addition to exclusion criteria: Presence of human anti-mouse antibody (HAMA) reactivity and Known hypersensitivity to murine antibodies or proteins. Typographical error in the protocol: The study outline should state that Zevalin is given weeks 9-13 and not weeks 9-12.
    14 Dec 2007
    Amendment made in light of new information that has been published or secondary to new investigations that may provide new scientific insights into how treatment modality works.
    24 Jun 2008
    A further substudy was added to the trial. Previously the trial included a single substudy, including both dosimetry procedures and analysis of biomarkers. Upon further discussion of the biomarker analysis, and after performing the initial dosimetry analyses, the timepoints at which samples for biomarker analysis will be obtained are updated, and dosimetry and biomarker analysis divided into two separate substudies, giving patients the option to consent to one, or to neither.
    17 Feb 2009
    Amendment to the biomarker study to update the timepoints at which samples for biomarker analysis will be obtained. An additional blood sample at a different timepoint has been added at Day -7, 1 week prior to treatment with Zevalin.
    06 Nov 2009
    Additional guidance added to the protocol regarding situations where the second infusion of 90Y Ibritumomab tiuxetan should be reduced/ omitted, in order to reduce the occurrence of serious haematological toxicities.
    22 Nov 2011
    To reduce the reporting time period for adverse events. Events occurring more than 30 days after completion of treatment are only now reported if they are considered related to treatment, during the 5 year follow up period.

    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.
    Primary completion date is a best guest estimate based on the date the last participant was enrolled, when their last IMP administration occurred and when they had their 3 month scan.
    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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