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    Clinical Trial Results:
    Allogeneic Transplantation of Haematopoietic Stem Cells Following Non-myeloablative Conditioning With Melphalan, Fludarabine, Thiotepa, Rituximab and Ibritumomab Tiuxetan (Zevalin) in Patients With Aggressive Non-Hodgkin's B-cell Lymphoma

    Summary
    EudraCT number
    		 2007-003302-10
    Trial protocol
    		 ES  
    Global end of trial date
    04 Feb 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2021
    First version publication date
    15 Jul 2021
    Other versions
    Summary report(s)
    		 Z-RIC

    Trial information

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    Trial identification
    Sponsor protocol code
    GELTAMO- Z-RIC - Allo
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00644371
    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
    04 Feb 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Progression-free survival
    Protection of trial subjects
    Patients with diagnosis of CD20 positive NHL, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), Burkitt’s lymphoma (BL) or grade 3b or transformed follicular lymphoma (FL) were considered for the study. Inclusion criteria were: achieving less than a partial response (PR) after 2 lines of treatment, relapse after autologous stem cell transplantation, positive PET after autologous stem cell transplantation or stem cell mobilization failure. Patients were eligible if they were between 18 and 65 years old, ECOG performance status was ≤2 and no major organ dysfunction was present (serum bilirubin < 2 mg/dL with AST, ALT, GGT and AP < 2 times ULN, left ventricular ejection fraction > 40% and serum creatinine < 2 mg/dL). Exclusion criteria included prior RIT, HIV associated lymphoma, pregnancy or breast feeding, severe comorbidities or known allergy to murine antibodies or Y-90.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2007
    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: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with diagnosis of CD20 positive NHL, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), Burkitt’s lymphoma (BL) or grade 3b or transformed follicular lymphoma (FL) were considered for the study. Patients were eligible if they were between 18 and 65 years old, ECOG performance status was ≤2

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 18
    Number of subjects completed
    		 18

    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
    Arm description
    		 Experimental arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ibritumomab Tiuxetan (Zevalin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    0.4 mCi/kg (14.8 MBq/kg). Maximum: 32 mCi on day -14.

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    250 mg/m2 on days -21 and -14 and 0.4 mCi/kg of Y-90-IB was administered after rituximab dose

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m2/day on days -7, -6, -5, -4 and -3 as a 30-min infusion.

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    70 mg/m2/day on days -3 and -2 as a 15-min infusion.

    Investigational medicinal product name
    Thiotepa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/kg over 4 hours every 12 hours on day -8.

    Number of subjects in period 1
    		Experimental
    Started
    18
    Completed
    18

    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
    		 18 18
    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)
    		 18 18
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with diagnosis of CD20 positive NHL, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), Burkitt’s lymphoma (BL) or grade 3b or transformed follicular lymphoma (FL) were considered for the study. Inclusion criteria were: achieving less than a partial response (PR) after 2 lines of treatment, relapse after autologous stem cell transplantation, positive PET after autologous stem cell transplantation or stem cell mobilization failure. Patients were eligible if they were between 18 and 65 years old, ECOG performance status was ≤2 and no major organ dysfunction was present (serum bilirubin < 2 mg/dL with AST, ALT, GGT and AP < 2 times ULN, left ventricular ejection fraction > 40% and serum creatinine < 2 mg/dL). Exclusion criteria included prior RIT, HIV associated lymphoma, pregnancy or breast feeding, severe comorbidities or known allergy to murine antibodies or Y-90.

    Subject analysis sets values
    		 Overall trial
    Number of subjects
    18
    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)
        From 65-84 years
    18
        85 years and over
    Age continuous
    Units: years
        arithmetic mean
    ( )
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    15

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Experimental arm

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients with diagnosis of CD20 positive NHL, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), Burkitt’s lymphoma (BL) or grade 3b or transformed follicular lymphoma (FL) were considered for the study. Inclusion criteria were: achieving less than a partial response (PR) after 2 lines of treatment, relapse after autologous stem cell transplantation, positive PET after autologous stem cell transplantation or stem cell mobilization failure. Patients were eligible if they were between 18 and 65 years old, ECOG performance status was ≤2 and no major organ dysfunction was present (serum bilirubin < 2 mg/dL with AST, ALT, GGT and AP < 2 times ULN, left ventricular ejection fraction > 40% and serum creatinine < 2 mg/dL). Exclusion criteria included prior RIT, HIV associated lymphoma, pregnancy or breast feeding, severe comorbidities or known allergy to murine antibodies or Y-90.

    Primary: Primary

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    End point title
    		 Primary
    End point description
    Progression-free survival
    End point type
    Primary
    End point timeframe
    12-months
    End point values
    		 Experimental Overall trial
    Number of subjects analysed
    18
    18
    Units: pfs
    18
    18
    Statistical analysis title
    		 Progression free survival
    Comparison groups
    Experimental v Overall trial
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 50
    Method
    		 Logrank
    Parameter type
    		 TTP
    Confidence interval
    Notes
    [1] - PFS

    Secondary: Secondary

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    End point title
    		 Secondary
    End point description
    safety (toxicity, transplantation- and graft-related mortality) response to treatment according to the Cheson's criteria (Cheson B, et al. JCO 25, 570, 2007). overall survival relapse rate acute and chronic Graft-versus-Host Disease haematological and immunological reconstitution, and chimerism. the impact of Complete Clinical Response, determined by flow cytometry and PET, on progression-free survival
    End point type
    Secondary
    End point timeframe
    36 months
    End point values
    		 Experimental
    Number of subjects analysed
    18
    Units: pfs
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On 4-year estimated PFS
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    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
    7 / 18 (38.89%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Septic shock
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 18 (16.67%)
         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
    11 / 18 (61.11%)
    Blood and lymphatic system disorders
    Infection
         subjects affected / exposed
    5 / 18 (27.78%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 18 (33.33%)
         occurrences all number
    1

    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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