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    Clinical Trial Results:
    Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed

    Summary
    EudraCT number
    		 2008-005687-13
    Trial protocol
    		 ES  
    Global end of trial date
    29 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jul 2021
    First version publication date
    17 Jul 2021
    Other versions
    Summary report(s)
    		 R-BMD

    Trial information

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    Trial identification
    Sponsor protocol code
    R-BMDGELTAMO08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01133158
    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 Transplante Autólogo de Médula Ósea , 0034 913195780, dm@geltamo.com
    Scientific contact
    GELTAMO, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea , 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
    29 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.
    Protection of trial subjects
    Patients eligible for inclusion were those aged 18‐75 years who had been previously diagnosed (lymph node or tissue biopsy) by a local pathologist and fulfilled the following criteria: FL grade, 1‐3a; Eastern Cooperative Oncology Group (ECOG) score, ≤2; Ann Arbor stage, I–IV; Follicular Lymphoma International Prognostic Index (FLIPI), 0‐5. Patients to whom any of the following exclusion criteria applied were considered ineligible: previous radiotherapy treatment; relapse after autologous stem cell transplantation central nervous system involvement; previous or concomitant malignant disease; clinical suspicion or histological confirmation of transformed lymphoma (in the staging bone marrow biopsy performed on each patient or in a new lymph node or tissue biopsy performed prior to inclusion in some patients with clinical suspicion of transformation); previous or active infection with hepatitis B virus, hepatitis C virus, or HIV; other serious immunosuppressive conditions; organ function deficits (liver, kidney, or heart) unrelated to lymphom
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Jul 2009
    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: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    32
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Sixty‐one patients were enrolled and assessed. After exclusion of one screen failure, 60 patients (median age, 62.5 years; range, 32‐76) received treatment according to the study protocol

    Period 1
    Period 1 title
    OVERALL STUDY (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental: R-BMD
    Arm description
    		 Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
    Arm type
    		 Experimental

    Investigational medicinal product name
    RITUXIMAB
    Investigational medicinal product code
    Other name
    Rituxan®
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

    Investigational medicinal product name
    BENDAMUSTINE
    Investigational medicinal product code
    Other name
    Bendeka, Belrapzo, Treanda
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    90 mg/m2/day, days 1 and 2 of each cycle

    Investigational medicinal product name
    MITOXANTRONE
    Investigational medicinal product code
    Other name
    Novantrone
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    6 mg/m2/day, day 1 of each cycle

    Investigational medicinal product name
    DEMAMETHASONE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Tablet
    Routes of administration
    Oral use, Intravenous use
    Dosage and administration details
    Dexamethasone 20 mg / day, days 1 through 5 of each cycle

    Number of subjects in period 1
    		Experimental: R-BMD
    Started
    60
    Completed
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OVERALL STUDY
    Reporting group description
    		 -

    Reporting group values
    		 OVERALL STUDY Total
    Number of subjects
    		 60 60
    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)
    		 32 32
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 30 30
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Number of Participants analyzed in the Maintenance Rituximab Arm reflects all participants who received at least one dose of Rituximab during maintenance, and had available data for response during that phase

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    60
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    32
        From 65-84 years
    28
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    30
        Male
    30

    End points

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    End points reporting groups
    Reporting group title
    Experimental: R-BMD
    Reporting group description
    		 Patient will receive Rituximab, Bendamustina, Mitoxantrone and Dexametasona Rituximab, Bendamustine, Mitoxantrone, Dexamethasone: Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv DEXAMETHASONE 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Number of Participants analyzed in the Maintenance Rituximab Arm reflects all participants who received at least one dose of Rituximab during maintenance, and had available data for response during that phase

    Primary: Response Rate: Primary End points

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    End point title
    		 Response Rate: Primary End points
    End point description
    The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL Complete Remission (CR): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD Progressive Disease (PD): SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion
    End point type
    Primary
    End point timeframe
    7 YEARS
    End point values
    		 Experimental: R-BMD Overall trial
    Number of subjects analysed
    60
    60
    Units: CR/uCR
    60
    60
    Statistical analysis title
    		 Complete analisis
    Comparison groups
    Experimental: R-BMD v Overall trial
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 50
    Method
    		 Logrank
    Parameter type
    		 TTP
    Confidence interval

    Secondary: Secondary End points

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    End point title
    		 Secondary End points
    End point description
    Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response. Secondary endpoints were toxicity, the role of rituximab maintenance to prolong the response and delay the next treatment, OS and PFS.
    End point type
    Secondary
    End point timeframe
    7 years
    End point values
    		 Experimental: R-BMD
    Number of subjects analysed
    60
    Units: OS and PFS
    60
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    9 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 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
    25 / 60 (41.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Left ventricular systolic dysfunction
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Surgery
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    12 / 60 (20.00%)
         occurrences causally related to treatment / all
    0 / 20
         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
    60 / 60 (100.00%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    43 / 60 (71.67%)
         occurrences all number
    144
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    18 / 60 (30.00%)
         occurrences all number
    58

    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? 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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