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    Clinical Trial Results:
    AN OPEN MULTICENTER PHASE II STUDY OF EFFICACY AND TOXICITY OF MAINTENANCE SUBCUTANEOUS RITUXIMAB AFTER RESCUE TREATMENT IN PATIENTS WITH RELAPSED OR REFRACTORY MANTLE-CELL LYMPHOMA NON-ELIGIBLE FOR AUTO OR ALLO STEM CELL TRANSPLANTATION.

    Summary
    EudraCT number
    		 2014-001911-38
    Trial protocol
    		 ES  
    Global end of trial date
    14 Aug 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Jul 2021
    First version publication date
    12 Jun 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of some items.

    Trial information

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    Trial identification
    Sponsor protocol code
    GELTAMOMAN2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02267915
    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 TRASPLANTES AUTOLOGO DE MEDULA OSEA (GELTAMO), 0034 913195780, sc@geltamo.com
    Scientific contact
    GELTAMO, GRUPO ESPAÑOL DE LINFOMAS Y TRASPLANTES AUTOLOGO DE MEDULA OSEA (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
    14 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy
    Protection of trial subjects
    Data base has been anonimated
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2014
    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: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    4
    From 65 to 84 years
    15
    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
    		 19
    Number of subjects completed
    		 19

    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
    		 Experimental: subcutaneous rituximab
    Arm description
    		 Experimental: subcutaneous rituximab MabThera 1400 mg solution for subcutaneous injection
    Arm type
    		 Experimental

    Investigational medicinal product name
    MABThera
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1400 mg

    Number of subjects in period 1
    		Experimental: subcutaneous rituximab
    Started
    19
    Completed
    19

    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
    		 19 19
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 13 13
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 3 3
    Subject analysis sets

    Subject analysis set title
    All
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy

    Subject analysis sets values
    		 All
    Number of subjects
    19
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    6
        From 65-84 years
    13
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    16
        Male
    3

    End points

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    End points reporting groups
    Reporting group title
    Experimental: subcutaneous rituximab
    Reporting group description
    		 Experimental: subcutaneous rituximab MabThera 1400 mg solution for subcutaneous injection

    Subject analysis set title
    All
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy

    Primary: Primary

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    End point title
    		 Primary
    End point description
    This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOxD. Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles. Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
    End point type
    Primary
    End point timeframe
    Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (RGemOxD)-induction therapy
    End point values
    		 Experimental: subcutaneous rituximab All
    Number of subjects analysed
    19
    19
    Units: month
        number (not applicable)
    19
    19
    Statistical analysis title
    		 Complete analisis
    Statistical analysis description
    Quantitative variables are described with measures of centralisation and dispersion (Mean, SD, Median, Minimum, Maximum, Q1 and Q3). Qualitative variables are described by absolute and relative frequencies. In the descriptive analysis of qualitative variables, two columns of percentages are presented, the total percentage (% total) and the valid percentage (% valid).
    Comparison groups
    Experimental: subcutaneous rituximab v All
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 50
    Method
    		 Logrank
    Parameter type
    		 TTP
    Point estimate
    18
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 19
    Notes
    [1] - Time to progression

    Secondary: Secondary

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    End point title
    		 Secondary
    End point description
    This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOxD. Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles. Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
    End point type
    Secondary
    End point timeframe
    Quality of response obtained after subcutaneous Rituximab maintenance. Progression-Free Survival (PFS) Overall Survival (OS) Time to Next Therapy (TTNT) Value of MRD in the disease outcome Toxicity
    End point values
    		 Experimental: subcutaneous rituximab
    Number of subjects analysed
    19
    Units: number
        median (standard deviation)
    66 ± 5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During all the clinic trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    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
    2 / 19 (10.53%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 2
         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
    14 / 19 (73.68%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    14 / 19 (73.68%)
         occurrences all number
    14

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jun 2017
    Missing of efficacity in the treatment
    -

    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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