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    Clinical Trial Results:
    TRATAMIENTO DE INDUCCIÓN CON RITUXIMAB + HYPER-CVAD Y ALTAS DOSIS DE METROTREXATO/CITARABINA Y CONSOLIDACIÓN CON Y90-IBRITUMOMAB TIUXETAN EN PACIENTES CON LINFOMA DE CELULAS DEL MANTO

    Summary
    EudraCT number
    		 2005-004400-37
    Trial protocol
    		 ES  
    Global end of trial date
    09 Sep 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2021
    First version publication date
    02 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GELTAMO-LCM 04-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00505232
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GELTAMO
    Sponsor organisation address
    H. MARQUES DE VALDECILLA SERVICIO DE HEMATOLOGIA, SANTANDER, Spain, 39008
    Public contact
    GELTAMO, Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO), 0034 913195780, dm@geltamo.com
    Scientific contact
    GELTAMO, Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO), 0034 913195780, sc@geltamo.com
    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
    09 Sep 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of the safety profile of the treatment regimen
    Protection of trial subjects
    Criteria for discontinuation of induction treatment If levels are not recovered within 5 weeks to allow chemotherapy to be given If grade 4 non-haematological toxicity, grade IV infection or severe bleeding (loss of 2 gr/dl of haemoglobin and life-threatening haemorrhage).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jan 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 30
    Number of subjects completed
    		 30

    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
    		 LCM ARM
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CICLOFOSFAMIDA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg/m2 /12 hours iv, days 1, 2, 3

    Investigational medicinal product name
    ADRIAMICINA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    25 mg/m2 iv, en infusión de 24 hours, days 4 y 5

    Investigational medicinal product name
    VINCRISTINA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1,4 mg/m2 iv (máximum 2 mg), infusion of 15’, day 4 y 11

    Investigational medicinal product name
    DEXAMETASONA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    40 mg/day, oral o iv, days 1 al 4 and 11 to 14

    Investigational medicinal product name
    RITUXIMAB
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m2 iv, day 1. The first cycle could be administered without rituximab to avoid cytokine release syndrome.

    Investigational medicinal product name
    IBRITUMOMAB –TIUXETAN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of 0.3 mCI/Kg to be scaled up to 0.4 mCi/kg, according to study design. It is administered as a 10-minute i.v. infusion.

    Number of subjects in period 1
    		LCM ARM
    Started
    30
    Completed
    30

    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
    		 30 30
    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)
    		 30 30
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    All inclusion criteria
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Age between 18-70 years. Diagnosis of mantle cell lymphoma (WHO classification 2008). General condition 0 - 2 on the Zubrod scale. Life expectancy greater than 3 months Adequate bone marrow reserve, unless due to infiltration by lymphoma. Hb 10 g/dL. PMN 1,500 cells/mm 3 platelets 100,000/mm3 Adequate hepatic, renal and cardiac function: creatinine <2.5x normal range, bilirubin or ALT/AST < 2.5x LSN (upper limit of normal) Cardiac LVEF > 50% (by echocardiography or perfusion scan). Signed written informed consent of the subject or his/her legal representative.

    Subject analysis sets values
    		 All inclusion criteria
    Number of subjects
    30
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    30
        From 65-84 years
        85 years and over
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    15

    End points

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    End points reporting groups
    Reporting group title
    LCM ARM
    Reporting group description
    		 -

    Subject analysis set title
    All inclusion criteria
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Age between 18-70 years. Diagnosis of mantle cell lymphoma (WHO classification 2008). General condition 0 - 2 on the Zubrod scale. Life expectancy greater than 3 months Adequate bone marrow reserve, unless due to infiltration by lymphoma. Hb 10 g/dL. PMN 1,500 cells/mm 3 platelets 100,000/mm3 Adequate hepatic, renal and cardiac function: creatinine <2.5x normal range, bilirubin or ALT/AST < 2.5x LSN (upper limit of normal) Cardiac LVEF > 50% (by echocardiography or perfusion scan). Signed written informed consent of the subject or his/her legal representative.

    Primary: Primary

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    End point title
    		 Primary
    End point description
    A response rate of more than 74% in patients treated with intensive first-line induction therapy (Rituximab + Hyper-CVAD and high-dose methotrexate/high-dose (Rituximab + Hyper-CVAD and high-dose methotrexate/cytarabine) 90-Ytrio-Ibritumomomab at full dose cytarabine) 90-Ytrio-Ibritumomab full-dose
    End point type
    Primary
    End point timeframe
    5 years
    End point values
    		 LCM ARM All inclusion criteria
    Number of subjects analysed
    30
    30
    Units: >74%
    30
    30
    Statistical analysis title
    		 Complete analisis
    Statistical analysis description
    The comparison will be made against a historical cohort on published data.
    Comparison groups
    LCM ARM v All inclusion criteria
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 > 70
    Method
    		 Kaplan-Meier
    Confidence interval
    Notes
    [1] - 70%

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 30 (80.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm
    Additional description: Second neoplasm
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    20 / 30 (66.67%)
         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
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 30 (66.67%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    19 / 30 (63.33%)
         occurrences all number
    1
    Infections and infestations
    Mucositis management
         subjects affected / exposed
    1 / 30 (3.33%)
         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
    15 Jan 2007
    see the induction treatment is modified so that the number of cycles will be 6, independent of age, rather than the 8 initially and not the 8 initially envisaged
    29 Oct 2007
    The obligation to pick up parents haematopoietic progenitors after the 5th cycle was withdrawn. Leaving collection to the discretion of the investigator

    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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