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    Clinical Trial Results:
    Phase II study of low intensity allogeneic transplantation in Mantle Cell Lymphoma

    Summary
    EudraCT number
    		 2007-003081-18
    Trial protocol
    		 GB  
    Global end of trial date
    25 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2020
    First version publication date
    26 Aug 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BRD/07/137
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00720447
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CTA number: 02666/0001/001, Cancer Research UK reference number: C7627/A9080
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    Joint Research Office, Gower Street, London, United Kingdom,
    Public contact
    Public contact, Cancer Research UK & UCL Cancer Trials Centre, ctc.sponsor@ucl.ac.uk
    Scientific contact
    Scientific contact, Cancer Research UK & UCL Cancer Trials Centre, ctc.sponsor@ucl.ac.uk
    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
    23 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to document the toxicity, feasibility and survival following reduced intensity allogeneic transplantation from HLA-compatible sibling or unrelated donors in patients with untreated Mantle Cell Lymphoma. The primary endpoint is progression free survival.
    Protection of trial subjects
    Stem-cell transplantations in the trial were conducted at experienced transplant centres familiar with the conditioning regimen. However, the centres may not have used it in this group of patients at this timepoint. The transplant and post-transplant procedures followed standard protocol. Campath (alemtuzumab) was used outside of its licensed indication (licensed for B-cell chronic lymphocytic leukaemia which is a low-grade NHL, as mantle cell lymphoma is). However, BEAM-Campath regimen has been routinely used as a conditioning regimen in allogeneic transplant to reduce the incidence of Graft Versus Host Disease for low grade lymphomas. Sites were required to keep drug accountability records. Only investigators/nurses experienced in using these IMPs according to the protocol were delegated treatment responsibilities. IDMC met annually to review safety data. Patients underwent screening evaluations to confirm eligibility for the trial, including full history and physical examination, pregnancy tests, biochemical examinations assessing liver and renal function, β2 microglobulin, serum LDH, virology (HIV, HBV, HCV, CMV and VZV status), assessment of cardiac function, confirmation of tissue type, STR analysis and ABO blood group. Donors were assessed for suitability for transplant, type of donor and CMV status. Patients were assessed regularly and the protocol gave guidance for supportive care for Graft versus host disease prophylaxis, infection prophylaxis and DLI therapy. Female patients potentially able to child bear needed to have a negative pregnancy test prior to commencing the trial drugs. Patients or their partners were recommended to use a barrier method of contraception during treatment and for one year after the last trial treatment.
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 The study is single arm and therefore no comparators were used.
    Actual start date of recruitment
    06 Jan 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    22
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The first patient was recruited to the trial on 06/01/2010. The final patient was recruited on 10/09/2013. In total, 25 patients were recruited and 12 sites were activated of which 8 recruited to the trial.

    Pre-assignment
    Screening details
    		 No screening information to provide for this trial. Patients were screened for eligibility for inclusion into the trial as per trial protocol.

    Period 1
    Period 1 title
    Main trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N.A

    Arms
    Arm title
    		 BEAM-Campath low intensity conditioning regimen
    Arm description
    		 All patients will receive the BEAM-Campath low intensity conditioning regimen outlined below prior to the allogeneic transplant. BCNU (Carmustine) 300mg/m2 administered over 2 hours on day -6 via IV (if Carmustine supplies are limited, site could administer Lomustine (CCNU) at a dose of 200mg/m2) Campath (Alemtuzumab): 10mg, administered over 2 hours on days -5 to -1 transplant via IV Ara-C (Cytarabine): 200mg/m2 two times a day, administered over 15 minutes on days -5 to -2 inclusive via IV Etoposide: 200mg/m2, administered over >1 hour on days -5 to -2 inclusive via IV Melphalan: 140mg/m2, adminisitered on day -1 via IV bolus Donor peripheral stem cell collection and patient administration of stem cells: G-CSF mobilised Peripheral blood stem cells (PBSC) are preferred (>4x106 CD34 + cells/kg) and should be collected as per local policy. However bone marrow may be used (nucleated cell dose > 3 x 108/kg required). Collection and administration of PBSC as per local policy.
    Arm type
    		 Single

    Investigational medicinal product name
    BCNU
    Investigational medicinal product code
    Other name
    Carmustine
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    300mg/m2 to be administered via IV over 2 hours on day -6 prior to transplant.

    Investigational medicinal product name
    Campath
    Investigational medicinal product code
    Other name
    Alemtuzumab
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10mg to be administered via IV over 2 hours on days -5 to -1 inclusive prior to infusion.

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Ara-C
    Pharmaceutical forms
    Solution for infusion, Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    200mg/m2 of Cytarabine to administered twice a day via IV over 15 minutes on days -5 to -2 inclusive prior to transplant.

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide 200mg/m2 to be administered via IV over >1 hour every day from day -5 to day -2 inclusive prior to transplant.

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Melphalan 140mg/m2 administered via IV bolus on day -1 prior to transplant.

    Investigational medicinal product name
    Lomustine
    Investigational medicinal product code
    Other name
    CCNU
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    In the event Carmustine supplies are limited, oral Lomustine (dose 200mg/m2) can be substituted (day -6 prior to transplant).

    Number of subjects in period 1
    		BEAM-Campath low intensity conditioning regimen
    Started
    25
    Completed
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BEAM-Campath low intensity conditioning regimen
    Reporting group description
    		 All patients will receive the BEAM-Campath low intensity conditioning regimen outlined below prior to the allogeneic transplant. BCNU (Carmustine) 300mg/m2 administered over 2 hours on day -6 via IV (if Carmustine supplies are limited, site could administer Lomustine (CCNU) at a dose of 200mg/m2) Campath (Alemtuzumab): 10mg, administered over 2 hours on days -5 to -1 transplant via IV Ara-C (Cytarabine): 200mg/m2 two times a day, administered over 15 minutes on days -5 to -2 inclusive via IV Etoposide: 200mg/m2, administered over >1 hour on days -5 to -2 inclusive via IV Melphalan: 140mg/m2, adminisitered on day -1 via IV bolus Donor peripheral stem cell collection and patient administration of stem cells: G-CSF mobilised Peripheral blood stem cells (PBSC) are preferred (>4x106 CD34 + cells/kg) and should be collected as per local policy. However bone marrow may be used (nucleated cell dose > 3 x 108/kg required). Collection and administration of PBSC as per local policy.

    Reporting group values
    		 BEAM-Campath low intensity conditioning regimen Total
    Number of subjects
    		 25 25
    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)
    		 22 22
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 22 22
    ECOG PS
    ECOG PS at diagnosis
    Units: Subjects
        ECOG score 1
    		 13 13
        ECOG score 0
    		 12 12
    Disease stage at diagnosis
    Units: Subjects
        Stage 1
    		 1 1
        Stage 3
    		 5 5
        Stage 4
    		 19 19
    Bulky disease
    Units: Subjects
        Absent
    		 18 18
        Present
    		 7 7
    Response to induction chemotherapy
    Units: Subjects
        CR
    		 11 11
        PR
    		 14 14
    MIPI
    Units: Subjects
        Low risk
    		 15 15
        Intermediate risk
    		 4 4
        High risk
    		 4 4
        Missing
    		 2 2
    Donor matching
    Units: Subjects
        Matched sibling
    		 11 11
        MUD
    		 14 14
    Time from diagnosis to AlloSCT
    Units: Days
        median (full range (min-max))
    		 274 (98 to 485) -
    Age at transplant
    Units: Years
        median (full range (min-max))
    		 54 (34 to 70) -

    End points

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    End points reporting groups
    Reporting group title
    BEAM-Campath low intensity conditioning regimen
    Reporting group description
    		 All patients will receive the BEAM-Campath low intensity conditioning regimen outlined below prior to the allogeneic transplant. BCNU (Carmustine) 300mg/m2 administered over 2 hours on day -6 via IV (if Carmustine supplies are limited, site could administer Lomustine (CCNU) at a dose of 200mg/m2) Campath (Alemtuzumab): 10mg, administered over 2 hours on days -5 to -1 transplant via IV Ara-C (Cytarabine): 200mg/m2 two times a day, administered over 15 minutes on days -5 to -2 inclusive via IV Etoposide: 200mg/m2, administered over >1 hour on days -5 to -2 inclusive via IV Melphalan: 140mg/m2, adminisitered on day -1 via IV bolus Donor peripheral stem cell collection and patient administration of stem cells: G-CSF mobilised Peripheral blood stem cells (PBSC) are preferred (>4x106 CD34 + cells/kg) and should be collected as per local policy. However bone marrow may be used (nucleated cell dose > 3 x 108/kg required). Collection and administration of PBSC as per local policy.

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS) [1]
    End point description
    The sample size was calculated using a Fleming design so is based on a number of patients alive and progression free at this point. 15/25 needed. The K-M estimate at 2 years was 68·0% (95% CI: 46·1–82·5), the plot is also given.
    End point type
    Primary
    End point timeframe
    The primary endpoint is the number of patients alive and progression free at 2 years.
    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: This was a single arm trial based on a Fleming design. The primary endpoint required 15/25 patients to be alive and progression free at 2 years - this does not require a statistical test. The K-M rate and it's confidence interval have also been presented in the description.
    End point values
    		 BEAM-Campath low intensity conditioning regimen
    Number of subjects analysed
    25
    Units: Patients
        Alive an progression free
    17
        Progressed or died before 2 years
    8
    Attachments
    		 PFS K-M curve
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    K-M rate at 3 years with 95% CI
    End point type
    Secondary
    End point timeframe
    OS at 3-years
    End point values
    		 BEAM-Campath low intensity conditioning regimen
    Number of subjects analysed
    25
    Units: percent
        number (confidence interval 95%)
    80 (58.4 to 91.2)
    Attachments
    		 OS K-M curve
    No statistical analyses for this end point

    Secondary: Non-relapse mortality (NRM)

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    End point title
    		 Non-relapse mortality (NRM)
    End point description
    Cumulative incidence of non-relapse mortality at 2 years. This is calculated using competing risks (relapse counted as a competing event)
    End point type
    Secondary
    End point timeframe
    NRM at 2 years
    End point values
    		 BEAM-Campath low intensity conditioning regimen
    Number of subjects analysed
    25
    Units: percent
        number (confidence interval 95%)
    13 (4.4 to 35.2)
    No statistical analyses for this end point

    Secondary: Cumulative incidence of relapse

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    End point title
    		 Cumulative incidence of relapse
    End point description
    End point type
    Secondary
    End point timeframe
    Cumulative incidence of relapse at 2 years. This is calculated using competing risks with NRM counting as a competing event.
    End point values
    		 BEAM-Campath low intensity conditioning regimen
    Number of subjects analysed
    25
    Units: percent
        number (confidence interval 95%)
    21 (9.3 to 43.5)
    No statistical analyses for this end point

    Secondary: Acute Graft vs Host Disease (GvHD)

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    End point title
    		 Acute Graft vs Host Disease (GvHD)
    End point description
    One patient who failed to engraft was excluded.
    End point type
    Secondary
    End point timeframe
    GvHD which occurs within 100 days of transplant
    End point values
    		 BEAM-Campath low intensity conditioning regimen
    Number of subjects analysed
    24 [2]
    Units: Patients
        Grade I
    7
        Grade II
    2
        No acute GvHD reported
    15
    Notes
    [2] - One patient failed to engraft and was excluded from GvHD analyses.
    No statistical analyses for this end point

    Secondary: Chronic Graft Vs Host disease (GvHD)

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    End point title
    		 Chronic Graft Vs Host disease (GvHD)
    End point description
    End point type
    Secondary
    End point timeframe
    Chronic GvHD is GvHD occurring after Day 100
    End point values
    		 BEAM-Campath low intensity conditioning regimen
    Number of subjects analysed
    24 [3]
    Units: Patients
        Limited
    6
        Extensive
    8
    Notes
    [3] - One patient who failed to engraft was excluded from all GvHD analyses
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events that occur between informed consent and 30 days post transplant. Note, non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after.
    Adverse event reporting additional description
    Advsrse events were recorded on trial CRFs. Serious Adverse Events were reported on SAE Report. AEs and SAES: Relationships are to treatment (i.e. any IMP)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    BEAM-Campath low intensity conditioning regimen
    Reporting group description
    		 All patients will receive the BEAM-Campath low intensity conditioning regimen outlined below prior to the allogeneic transplant. BCNU (Carmustine) 300mg/m2 administered over 2 hours on day -6 via IV (if Carmustine supplies are limited, site could administer Lomustine (CCNU) at a dose of 200mg/m2) Campath (Alemtuzumab): 10mg, administered over 2 hours on days -5to -1 inclusive via IV Ara-C (Cytarabine): 200mg/m2 two times a day, administered over 15 minutes on days -5 to -2 inclusive via IV Etoposide: 200mg/m2, administered over >1 hour on days -5 to -2 inclusive via IV Melphalan: 140mg/m2, adminisitered on day -1 via IV bolus Donor peripheral stem cell collection and patient administration of stem cells: G-CSF mobilised Peripheral blood stem cells (PBSC) are preferred (>4x106 CD34 + cells/kg) and should be collected as per local policy. However bone marrow may be used (nucleated cell dose > 3 x 108/kg required). Collection and administration of PBSC as per local policy.

    Serious adverse events
    		 BEAM-Campath low intensity conditioning regimen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 25 (24.00%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    1
    Investigations
    Laboratory test abnormal
    Additional description: Low cyclosporine level
    alternative dictionary used: MedDRA 23
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 23
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fever
    alternative dictionary used: MedDRA 23
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chest wall pain
    alternative dictionary used: MedDRA 23
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection with normal ANC
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Opportunistic infection
    Additional description: Opportunistic infection (CMV)
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphopenia
    Additional description: Opportunistic infection lymphopenia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection with unknown ANC
         subjects affected / exposed
    1 / 25 (4.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BEAM-Campath low intensity conditioning regimen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 25 (96.00%)
    Investigations
    Haemoglobin
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [1]
    17 / 24 (70.83%)
         occurrences all number
    17
    Neutrophil count
         subjects affected / exposed [2]
    24 / 24 (100.00%)
         occurrences all number
    24
    Platelet count
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [3]
    8 / 24 (33.33%)
         occurrences all number
    8
    Weight loss
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [4]
    9 / 24 (37.50%)
         occurrences all number
    9
    Bilirubin
         subjects affected / exposed [5]
    2 / 24 (8.33%)
         occurrences all number
    2
    Calcium deficiency
         subjects affected / exposed [6]
    3 / 24 (12.50%)
         occurrences all number
    3
    Phosphate - serum low
         subjects affected / exposed [7]
    2 / 24 (8.33%)
         occurrences all number
    2
    Potassium - serum low
         subjects affected / exposed [8]
    4 / 24 (16.67%)
         occurrences all number
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed [9]
    3 / 24 (12.50%)
         occurrences all number
    3
    Headache
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [10]
    5 / 24 (20.83%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [11]
    14 / 24 (58.33%)
         occurrences all number
    14
    Fever
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [12]
    15 / 24 (62.50%)
         occurrences all number
    15
    mucositis
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [13]
    20 / 24 (83.33%)
         occurrences all number
    20
    Oedema
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [14]
    2 / 24 (8.33%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Oedema peripheral
         subjects affected / exposed [15]
    2 / 24 (8.33%)
         occurrences all number
    2
    Immune system disorders
    Anaphylactic reaction
    Additional description: Allergy/ Anaphylaxis
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [16]
    4 / 24 (16.67%)
         occurrences all number
    4
    Eye disorders
    Dry eye
         subjects affected / exposed [17]
    2 / 24 (8.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed [18]
    3 / 24 (12.50%)
         occurrences all number
    3
    anorexia
         subjects affected / exposed [19]
    13 / 24 (54.17%)
         occurrences all number
    13
    Constipation
         subjects affected / exposed [20]
    7 / 24 (29.17%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed [21]
    23 / 24 (95.83%)
         occurrences all number
    23
    Heartburn
         subjects affected / exposed [22]
    2 / 24 (8.33%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed [23]
    22 / 24 (91.67%)
         occurrences all number
    22
    Vomiting
         subjects affected / exposed [24]
    9 / 24 (37.50%)
         occurrences all number
    9
    Abdominal pain
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [25]
    2 / 24 (8.33%)
         occurrences all number
    2
    Proctalgia
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [26]
    2 / 24 (8.33%)
         occurrences all number
    2
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed [27]
    3 / 24 (12.50%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [28]
    4 / 24 (16.67%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed [29]
    7 / 24 (29.17%)
         occurrences all number
    7
    Rash
         subjects affected / exposed [30]
    14 / 24 (58.33%)
         occurrences all number
    14
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative dictionary used: MedDRA 23
         subjects affected / exposed [31]
    4 / 24 (16.67%)
         occurrences all number
    4
    Infections and infestations
    Fungal infection
         subjects affected / exposed [32]
    2 / 24 (8.33%)
         occurrences all number
    2
    Neutropenic sepsis
         subjects affected / exposed [33]
    10 / 24 (41.67%)
         occurrences all number
    10
    Infection
    Additional description: infection with unknown anc
         subjects affected / exposed [34]
    2 / 24 (8.33%)
         occurrences all number
    2
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: non-serious AE data is provided for 24 patients as one trial patient received a trial transplant but failed to engraft and had non-trial transplant soon after

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2009
    Pg 3: The name of the Lymphoma Trials Office has been changed to the Haematology Trials Group. A study outline has been provided in section 1.1 Sect 7: The inclusion and exclusion criteria for registration and for proceeding to allograft have been amalgamated into one section to make this clearer for sites. Sect 9: This has been updated in line with the current procedures at the Cancer Trials Centre Sect 10.2: A sentence regarding the substitution of Lomustine for Carmustine has been added. This is due to Carmustine supplied currently being limited in the UK. Sect 11.6: Information regarding Lomustine Drug Supply, Formulation, Administration and Storage has been added. Sect 12.2: A paragraph about supportive care for patients taking part in this regimen has been added. Sect 14: It has been decided to monitor chimerism for 2 years only, not 3 years. This is standard for all transplant patients. Sect 15: Point number 3 has been removed as there is no 8 week scan in this trial. This was incorrect in the previous version. Sect 16: It has been decided to follow patients up every 3 months for 2 years, and then annually until death. This follows the standard follow up procedure for transplant patients.S Sect 16.1.2: Time to engraftment has been added as an investigation at 3 months post transplant, in order to assess the degree of success of the transplant. Sect 18: This section has been updated to reflect the new phamacovigilance template released at the Cancer trials centre. Appendix 1: Glossary, has been moved from the start of the protocol into an Appendix. App 4: Assessment of GvHD, has been added as Appendix 4, as there was previously no assessment information for GvHD contained in the protocol. App5 : Expected AEs. This section includes Expected Adverse Event for all the IMP’s concerned in this trial, and has been entered in the updated format as required by the Cancer Trials Centre. App 6: Assessment Schedule: A schedule of Assesments included
    29 Jul 2010
    Inclusion criteria has been amended to allow for buccal swab to be taken from patient and donor for chimerism studies prior to transplant in section 7.1 • Exclusion criteria has been amended to clarify the serology positivity for HIV, HBV and HCV in section 7.2 • Exclusion criteria has been amended to clarify what inadequate cardiac function is (ejection fraction must be > 50% if assessed by ECHO or >40% if assessed by radionuclide ventriculography in section 7.2 • Bone marrow aspirates and trephines will be required only at 3 months post transplant if there is a prior involvement in section 16.1.2 • A requirement that patients should begin therapy with the study drug within 2 weeks of registration has been added in section 9.0. • The requirement for sites to do an evaluation of expectedness of SAEs has been removed from section 18.2.2 and transferred to UCL CTC • A requirement to obtain consent to report information from the mother if not a trial patient in case of pregnancy has been added in section 18.5 and a new Pregnancy Partner Information Sheet and Consent Form have been created • A list of AEs expected for the treatment regimen post allogeneic transplant has been added. A reference to the most recent SmPC for each of the IMPs has been included in case when the event does not appear on the list of AEs for the treatment regimen. Previous lists of AEs for each separate IMP have been removed. • The following new sections have been added to the protocol: section 7.3 on informed consent, section 7.4 on screening logs, section 7.6 on pregnancy and birth control, section 12.4 on management after treatment withdrawal, section 20.0 on trial closure and archiving, section 21.0 on trial monitoring and oversight, section 22.0 on data management guide, section 23.0 on withdrawal of patients
    27 Oct 2012
    The following changes have been made to the MiniAllo protocol • A section (6.1.2) on training requirements for site staff has been included • A section (8.1.1) clarifying the assessments to be done to confirm response to the induction chemotherapy given has been added • A section (8.1.2) clarifying the timeline for some baseline assessments has been added • Section 11 (previously Drug supply), now ‘Drug supply and accountability’, gives more information on keeping appropriate records on the trial drugs • Section 18 (Pharmacovigilance) of the protocol has been updated to include various current information on the reporting of Serious Adverse Events, pregnancies and their processing at UCL CTC • Section 18.3 – Clinical Review has been removed • Section 18.6 (previously Annual Safety Report(ASRs)), has now been updated to ‘Development Safety Update Reports (DSURs)’ • Section 21 (Trial monitoring and oversight) has been updated to reflect the current monitoring and oversight for the trial. • Section 24.6 – sponsorship details have been updated • Appendix 5 (Expected Adverse Events) – the AEs listed have been changed from ‘for the Treatment Regimen’ to ‘for Allogeneic Transplants’. These changes have been made to clarify some information in the protocol and also to make some baseline assessments timelines compatible with local procedures and time frames.

    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.
    Non-serious AEs includes serious and non-serious AEs. Threshold for reporting = >5% Occurrences all is the number of subjects affected since worst grade was reported by sites
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