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    Clinical Trial Results:
    Phase II trial on safety and activity of intensive short-term chemoimmunotherapy in HIV-positive patients with Burkitt's lymphoma.

    Summary
    EudraCT number
    		 2011-003487-75
    Trial protocol
    		 IT  
    Global end of trial date
    24 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Nov 2022
    First version publication date
    01 Nov 2022
    Other versions
    Summary report(s)
    		 carmen trial pubblication

    Trial information

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    Trial identification
    Sponsor protocol code
    CARMEN
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01516593
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS OSPEDALE SAN RAFFAELE
    Sponsor organisation address
    VIA OLGETTINA 60, MILAN, Italy,
    Public contact
    Oncologia, U. D. Tumori Linfoidi, Fondazione Centro San Raffaele del Monte Tabor, +39 02 26437649, ferreri.andres@hsr.it
    Scientific contact
    Oncologia, U. D. Tumori Linfoidi, Fondazione Centro San Raffaele del Monte Tabor, +39 02 26437649, ferreri.andres@hsr.it
    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
    01 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the activity in terms of complete remission rate (defined according to Cheson's criteria) at the end of the induction phase of the investigational intensive chemotherapy in HIV+ patients with Burkitt's lymphoma.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Twenty patients (median age 42, range 26–58; 16 males) were recruited at seven centres between May 2012 and December 2015. The trial was ended after accrual completion, and the database lock for the primary analysis was August 1, 2019.

    Pre-assignment
    Screening details
    		 Targeted population: HIV-positive patients affected by Burkitt’s Lymphoma aged between 18-60 years old, with organ functionality adequate to receive high-dose chemotherapy.

    Period 1
    Period 1 title
    Overll Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 induction and consolidation
    Arm description
    		 The phase includes administration of the following drugs: - Methylprednisolone; Cyclophosphamide; Vincristine (VCR); Rituximab; Methotrexate (MTX); etoposide (VP-16) 250 mg/m2 q12h; MTX with leucovorin rescue therapy; Doxorubicin (ADM); At the end of induction phase, initial sites of disease should be fully re-examined and, in selected cases assessed by surgical biopsy. - Patients in complete remission (CR) after induction phase will be referred to consolidation phase, followed by bulky site irradiation. - Patients in partial response (PR) after induction will be referred to consolidation phase followed by FEAM conditioning regimen supported by autologous stem-cell transplant (ASCT) and bulky irradiation. - Patients with stable disease (SD) after or with progressive disease (PD) during/after induction will be referred to intensification phase, followed by FEAM conditioning regimen supported by autologous stem cell transplant (ASCT) and bulky irradiation.
    Arm type
    		 single arm

    Investigational medicinal product name
    rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    375 mg/m2

    Investigational medicinal product name
    cyclophosophamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    500 mg/(m2 over 1h infusion

    Investigational medicinal product name
    doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    50 mg/m2 i.v. bolus

    Investigational medicinal product name
    vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    2mg total dose i.v. bolus

    Investigational medicinal product name
    methylprednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    0.5 - 1 mg/kg/d i.v.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    2g/m2 in 3-h infusion, twice a day ( every 12h)

    Investigational medicinal product name
    etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    250mg/m2 every 12h

    Investigational medicinal product name
    methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    12mg

    Number of subjects in period 1
    		induction and consolidation
    Started
    20
    Completed
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overll Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overll Trial Total
    Number of subjects
    		 20 20
    Age categorical
    twenty patients ( median age 42, range 26-58; 16 males) were recruited at seven centres between May 2012 and December 2015.
    Units: Subjects
        Adults (18-64 years)
    		 20 20
    Age continuous
    Units: years
        median (full range (min-max))
    		 42 (26 to 58) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    induction and consolidation
    Reporting group description
    		 The phase includes administration of the following drugs: - Methylprednisolone; Cyclophosphamide; Vincristine (VCR); Rituximab; Methotrexate (MTX); etoposide (VP-16) 250 mg/m2 q12h; MTX with leucovorin rescue therapy; Doxorubicin (ADM); At the end of induction phase, initial sites of disease should be fully re-examined and, in selected cases assessed by surgical biopsy. - Patients in complete remission (CR) after induction phase will be referred to consolidation phase, followed by bulky site irradiation. - Patients in partial response (PR) after induction will be referred to consolidation phase followed by FEAM conditioning regimen supported by autologous stem-cell transplant (ASCT) and bulky irradiation. - Patients with stable disease (SD) after or with progressive disease (PD) during/after induction will be referred to intensification phase, followed by FEAM conditioning regimen supported by autologous stem cell transplant (ASCT) and bulky irradiation.

    Primary: CRR AFTER INDUCTION CHEMOIMMUNOTHERAPY

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    End point title
    		 CRR AFTER INDUCTION CHEMOIMMUNOTHERAPY [1]
    End point description
    CRR according to investigator assessment was used as supportive evidence.
    End point type
    Primary
    End point timeframe
    60 days
    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: The primary endpoint was CRR after induction chemoimmunotherapy. CRR according to investigator assessment was used as supportive evidence. The two-stage Simon optimal design was used to test the null hypothesis that the true CRR after the induction phase is 40% (considered unacceptable) as opposed to the alternative hypothesis of 70% (considered of interest). It's a single arm study and no comparison group was evaluated.
    End point values
    		 induction and consolidation
    Number of subjects analysed
    20
    Units: decimal number
    20
    No statistical analyses for this end point

    Secondary: toxicity and activity of the whole programme

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    End point title
    		 toxicity and activity of the whole programme
    End point description
    toxicity, activity of the whole programme, progression-free survival (PFS) and OS were the seconday end-points.
    End point type
    Secondary
    End point timeframe
    60 days
    End point values
    		 induction and consolidation
    Number of subjects analysed
    20
    Units: DECIMAL NUMBER
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    5years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: no non-serious adverse events were recorded.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2013
    administrative reaison.
    08 May 2018
    The amendment introduces the centralized pathological review of patient tumor biopsy samples collected prior to entry into the study. The aim is to reclassify tumors according to the new WHO nomenclature of 2016 and to assess whether there is a correlation with the clinical response.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33090470
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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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