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    Clinical Trial Results:
    Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in patients with diffuse large B-cell lymphoma

    Summary
    EudraCT number
    		 2006-005174-42
    Trial protocol
    		 NL   DK   BE  
    Global end of trial date
    03 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON84NHL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    HOVON Data Center, HOVON, 31 107041560, hdc@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON, 31 107041560, hdc@erasmusmc.nl
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess in a prospective, multicenter, randomized phase III study in patients with DLBCL the effect of early intensification of rituximab combined with 2-weekly CHOP +G-CSF (CHOP14) in comparison to no intensification of rituximab on the response rate (complete remission and FDG-PET negative partial remission/unconfirmed complete remission) and time to reach response
    Protection of trial subjects
    Monitoring and Insurance
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2007
    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
    Netherlands: 461
    Country: Number of subjects enrolled
    Belgium: 26
    Country: Number of subjects enrolled
    Denmark: 113
    Worldwide total number of subjects
    600
    EEA total number of subjects
    600
    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)
    301
    From 65 to 84 years
    299
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 For young patients 18-65 (inclusive) years: Arm A: 8 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta). Rituximab (MabThera) will be administered at day 1 of each cycle For elderly patients 66-80 (inclusive) years: Arm A: 6 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta). Rituximab (MabThera) will be administered at day 1 of cycle I-V, and at day 1, 15 and 29 of cycle VI
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    18-65 years: 100mg on day -4, -3, -2, -1, 0 66-80 years: 100mg on day -4, -3, -2, -1, 0

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    18-65 years: 750mg/m2 on day 1 66-80 years: 750mg/m2 on day 1

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    18-65 years: 50mg/m2 on day 1 66-80 years: 50 mg/m2 on day 1

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    18-65 years: 1.4 mg/m2 (max 2mg) on day 1 66-80 years: 1.4 mg/m2 (max 2mg) on day 1

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    18-65 years: 100mg on day 1, 2, 3, 4, 5 66-80 years: 100mg on day 1, 2, 3, 4, 5

    Investigational medicinal product name
    G-CSF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    18-65 years: 6mg on day 2 66-80 years: 6mg on day 2

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    18-65 years: 375 mg/m2 (max 750mg) on day 1 66-80 years: 375 mg/m2 (max 750mg) on day 1 (cycle I-V) and on day 1, 15, 29 (cycle VI)

    Arm title
    		 Arm B
    Arm description
    		 For young patients 18-65 (inclusive) years: Arm B: 8 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first 4 cycles. Rituximab will be administered at day 1 and 8 of cycle I-IV and at day 1 of cycle V-VIII For elderly patients 66-80 (inclusive) years: Arm B: 6 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first 4 cycles. Rituximab will be administered at day 1 and 8 of cycle I-IV, at day 1 of cycle V, and at day 1, 15 and 29 of cycle VI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    18-65 years: 100mg on day -4, -3, -2, -1, 0 66-80 years: 100mg on day -4, -3, -2, -1, 0

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    18-65 years: 750mg/m2 on day 1 66-80 years: 750mg/m2 on day 1

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    18-65 years: 50mg/m2 on day 1 66-80 years: 50 mg/m2 on day 1

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    18-65 years: 1.4 mg/m2 (max 2mg) on day 1 66-80 years: 1.4 mg/m2 (max 2mg) on day 1

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    18-65 years: 100mg on day 1, 2, 3, 4, 5 66-80 years: 100mg on day 1, 2, 3, 4, 5

    Investigational medicinal product name
    G-CSF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    18-65 years: 6mg on day 2 66-80 years: 6mg on day 2

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Infusion
    Dosage and administration details
    18-65 years: 375 mg/m2 (max 750mg) on day 1, 8 (cycle I-IV) and on day 1 (cycle V-VIII) 66-80 years: 375 mg/m2 (max 750mg) on day 1, 8 (cycle I-IV) and on day 1, (cycle V) and on day 1, 15, 29 (cycle VI)

    Number of subjects in period 1
    		Arm A Arm B
    Started
    300
    300
    Completed
    176
    177
    Not completed
    124
    123
         Adverse events, all combined
    27
    21
         Other
    38
    39
         Lost to follow-up
    -
    1
         Lack of efficacy
    59
    62

    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
    		 600 600
    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)
    		 301 301
        From 65-84 years
    		 299 299
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 65 (18 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 291 291
        Male
    		 309 309

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 For young patients 18-65 (inclusive) years: Arm A: 8 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta). Rituximab (MabThera) will be administered at day 1 of each cycle For elderly patients 66-80 (inclusive) years: Arm A: 6 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta). Rituximab (MabThera) will be administered at day 1 of cycle I-V, and at day 1, 15 and 29 of cycle VI

    Reporting group title
    Arm B
    Reporting group description
    		 For young patients 18-65 (inclusive) years: Arm B: 8 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first 4 cycles. Rituximab will be administered at day 1 and 8 of cycle I-IV and at day 1 of cycle V-VIII For elderly patients 66-80 (inclusive) years: Arm B: 6 cycles of R-CHOP14 plus G-CSF: pegfilgrastim (Neulasta) with intensification of rituximab (MabThera) during the first 4 cycles. Rituximab will be administered at day 1 and 8 of cycle I-IV, at day 1 of cycle V, and at day 1, 15 and 29 of cycle VI

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    See publication
    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: Statistical analysis has been uploaded in the chart section.
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    286
    288
    Units: Whole
    286
    288
    Attachments
    		 List of reported SAE's
    List of reported non-SAE's
    Statistical data section from publication
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events of Grade 2 or higher, with the exception of progression of disease, occurring during the protocol treatment period will be reported. Adverse events occurring after that period should also be reported if considered related to protocol.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Serious adverse events
    		 Arm A Arm B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    151 / 297 (50.84%)
    144 / 298 (48.32%)
         number of deaths (all causes)
    106
    128
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    6 / 297 (2.02%)
    5 / 298 (1.68%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 5
         deaths causally related to treatment / all
    1 / 3
    0 / 2
    Vascular disorders
    Vascular disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    9 / 297 (3.03%)
    6 / 298 (2.01%)
         occurrences causally related to treatment / all
    5 / 9
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Surgical and medical procedures
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    2 / 297 (0.67%)
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    24 / 297 (8.08%)
    31 / 298 (10.40%)
         occurrences causally related to treatment / all
    20 / 27
    26 / 34
         deaths causally related to treatment / all
    0 / 2
    1 / 1
    Immune system disorders
    Immune system disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    2 / 297 (0.67%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    20 / 297 (6.73%)
    20 / 298 (6.71%)
         occurrences causally related to treatment / all
    8 / 21
    14 / 21
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Psychiatric disorders
    Psychiatric disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    4 / 297 (1.35%)
    4 / 298 (1.34%)
         occurrences causally related to treatment / all
    3 / 4
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Investigations
    Investigations
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    5 / 297 (1.68%)
    6 / 298 (2.01%)
         occurrences causally related to treatment / all
    5 / 5
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 297 (0.00%)
    4 / 298 (1.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    14 / 297 (4.71%)
    15 / 298 (5.03%)
         occurrences causally related to treatment / all
    8 / 17
    12 / 18
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    7 / 297 (2.36%)
    13 / 298 (4.36%)
         occurrences causally related to treatment / all
    4 / 9
    8 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    40 / 297 (13.47%)
    40 / 298 (13.42%)
         occurrences causally related to treatment / all
    57 / 62
    51 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    36 / 297 (12.12%)
    30 / 298 (10.07%)
         occurrences causally related to treatment / all
    27 / 45
    26 / 39
         deaths causally related to treatment / all
    2 / 2
    3 / 3
    Hepatobiliary disorders
    Hepatobiliary disorder
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    3 / 297 (1.01%)
    0 / 298 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Endocrine disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 298 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    9 / 297 (3.03%)
    2 / 298 (0.67%)
         occurrences causally related to treatment / all
    3 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    52 / 297 (17.51%)
    39 / 298 (13.09%)
         occurrences causally related to treatment / all
    55 / 66
    44 / 51
         deaths causally related to treatment / all
    4 / 5
    3 / 4
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details
         subjects affected / exposed
    7 / 297 (2.36%)
    9 / 298 (3.02%)
         occurrences causally related to treatment / all
    6 / 9
    2 / 9
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm A Arm B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    286 / 297 (96.30%)
    285 / 298 (95.64%)
    Surgical and medical procedures
    Surgery/intra-operative injury
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 298 (0.34%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Growth and development
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 297 (0.67%)
    0 / 298 (0.00%)
         occurrences all number
    3
    0
    Secondary malignancy
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 297 (0.67%)
    2 / 298 (0.67%)
         occurrences all number
    2
    2
    Syndroms
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    6 / 297 (2.02%)
    4 / 298 (1.34%)
         occurrences all number
    6
    4
    Immune system disorders
    Allergy/immunology
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    5 / 297 (1.68%)
    9 / 298 (3.02%)
         occurrences all number
    5
    10
    Constitutional symptoms
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    107 / 297 (36.03%)
    130 / 298 (43.62%)
         occurrences all number
    168
    191
    Infection
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    96 / 297 (32.32%)
    92 / 298 (30.87%)
         occurrences all number
    143
    139
    Reproductive system and breast disorders
    Sexual/reproductive function
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    1 / 297 (0.34%)
    4 / 298 (1.34%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Pulmonary/upper respiratory
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    34 / 297 (11.45%)
    47 / 298 (15.77%)
         occurrences all number
    41
    69
    Cardiac disorders
    Cardiac arrythmia
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    17 / 297 (5.72%)
    16 / 298 (5.37%)
         occurrences all number
    19
    16
    Cardiac general
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    7 / 297 (2.36%)
    22 / 298 (7.38%)
         occurrences all number
    7
    27
    Nervous system disorders
    Neurology
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    154 / 297 (51.85%)
    174 / 298 (58.39%)
         occurrences all number
    208
    251
    Pain
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    49 / 297 (16.50%)
    47 / 298 (15.77%)
         occurrences all number
    73
    66
    Blood and lymphatic system disorders
    ANC
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    134 / 297 (45.12%)
    155 / 298 (52.01%)
         occurrences all number
    329
    397
    Anemia
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    217 / 297 (73.06%)
    214 / 298 (71.81%)
         occurrences all number
    766
    742
    Coagulation
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    3 / 297 (1.01%)
    4 / 298 (1.34%)
         occurrences all number
    3
    4
    Hemorrhage/bleeding
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    2 / 297 (0.67%)
    4 / 298 (1.34%)
         occurrences all number
    2
    4
    Lymphatics
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    11 / 297 (3.70%)
    13 / 298 (4.36%)
         occurrences all number
    11
    16
    Platelets
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    64 / 297 (21.55%)
    71 / 298 (23.83%)
         occurrences all number
    154
    133
    Vascular
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    28 / 297 (9.43%)
    21 / 298 (7.05%)
         occurrences all number
    28
    23
    WBC
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    170 / 297 (57.24%)
    194 / 298 (65.10%)
         occurrences all number
    456
    592
    Ear and labyrinth disorders
    Auditory/ear
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    3 / 297 (1.01%)
    6 / 298 (2.01%)
         occurrences all number
    3
    6
    Eye disorders
    Ocular/visual
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    8 / 297 (2.69%)
    15 / 298 (5.03%)
         occurrences all number
    8
    18
    Gastrointestinal disorders
    Gastrointestinal
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    119 / 297 (40.07%)
    123 / 298 (41.28%)
         occurrences all number
    222
    220
    Skin and subcutaneous tissue disorders
    Dermatology/Skin
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    74 / 297 (24.92%)
    59 / 298 (19.80%)
         occurrences all number
    98
    73
    Renal and urinary disorders
    Renal/genitourinary
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    16 / 297 (5.39%)
    19 / 298 (6.38%)
         occurrences all number
    19
    23
    Endocrine disorders
    Endocrine
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    10 / 297 (3.37%)
    10 / 298 (3.36%)
         occurrences all number
    10
    12
    Hepatobiliary/pancreas
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 298 (0.34%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal/soft tissue
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    18 / 297 (6.06%)
    25 / 298 (8.39%)
         occurrences all number
    21
    32
    Metabolism and nutrition disorders
    Metabolic/laboratory
    Additional description: All combined, see non-SAE chart for details
         subjects affected / exposed
    38 / 297 (12.79%)
    39 / 298 (13.09%)
         occurrences all number
    78
    86

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2009
    Change in the number of R-CHOP14 cycles for the elderly patient group aged 66-80 years from 8 cycles to 6 cycles. The number of rituximab administrations will remain the same; the rituximab administrations at cycle 6 will be given at days 1, 15 and 29. This change is based on the publication of the RICOVER-60 trial by the German High Grade Lymphoma Study Group. Inclusion of young patients aged 18-65 years with an age-adjusted IPI score of 1-3. Changes and clarification of PET scan (review) procedures Administrative corrections (i.e. new phone and fax numbers Erasmus MC, change of statistician)

    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
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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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