Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase II study of R-CHOP with intensive CNS prophylaxis and scrotal irradiation in patients with primary testicular diffuse large B-cell lymphoma

    Summary
    EudraCT number
    		 2009-011789-26
    Trial protocol
    		 IT  
    Global end of trial date
    29 Sep 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Feb 2025
    First version publication date
    24 Oct 2024
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    The dataset was reviewed, but no change was made
    Summary report(s)
    		 IELSG30 Synopsis Results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IELSG30
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00945724
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    International Extranodal Lymphoma Study Group (IELSG)
    Sponsor organisation address
    Via Vincenzo Vela 6, Bellinzona, Switzerland, 6500
    Public contact
    Uffici Studi FIL, Fondazione Italiana Linfomi - ETS, +39 0599769918, startup@filinf.it
    Scientific contact
    Uffici Studi FIL, Fondazione Italiana Linfomi - ETS, +39 0599769918, startup@filinf.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
    29 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate safety and feasibility of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy in untreated patient with stage I and II Primary Testicular Lymphoma
    Protection of trial subjects
    Guidelines for dose modifications were included in the study protocol, in order to minimize any possible risks for the patients. All concomitant medications for medical conditions other than B-NHL are permitted, as clinically indicated. All supportive therapies other than anti-cancer treatment needed for the management of patients enrolled in this study are permitted During treatment the following therapies were recommended as concomitant therapy: - Premedication for rituximab infusion with paracetamol and diphenhydramine is mandatory before each infusion of rituximab, because it may reduce infusion reactions. - Use of corticosteroids is allowed as pre-medication for rituximab infusion. - Pre-phase therapy is recommended in older patients (>65 years) with PDN 100 mg/die for 10 days and VCR 1.5 mg total dose - G-CSF or Peg-Filgrastim as primary prophylaxis for the prevention of febrile neutropenia in older (>65 years) patients and in presence of neutropenia < 1.0 x 109/L. - Cotrimoxazole BACTRIM 3 tablets/week (or 1 x 2/day for two days/week) or Pentamidine aerosol every 15 days in patients with Bactrim allergy or in patients with G6PD deficiency throughout the treatment and consolidation phase. - Platelets and red blood cell transfusion in case of Hb < 8 g/dL or Plts < 10 x 109/L. - Laxatives and other prebiotics and probiotics to prevent constipation and should be administered according to standard practice - Antiemetic agents
    Background therapy
    		 - Antiviral prophylaxis with acyclovir 800-1200 mg at day since the beginning of therapy in patients with herpes virus infection reactivation. Additional prophylaxis with levofloxacin or ciprofloxacin to be administered in case of neutropenia <1.0 x 109/l. - In patients with Ab antiHBcAg +, Ab antiHBsAg +/- prophylaxis against hepatitis B reactivation with Lamivudine 100 mg/die from the start of the treatment to one year after the end of the treatment.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 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
    Italy: 47
    Country: Number of subjects enrolled
    Switzerland: 7
    Worldwide total number of subjects
    54
    EEA total number of subjects
    47
    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)
    27
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment lasted from 27 September 2009 to 13 July 2017.

    Pre-assignment
    Screening details
    		 Fifty four patients were screened and all were enrolled and treated.

    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
    		 Arm 1
    Arm description
    		 Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m2 on day o or day 1 of R-CHOP regimen for six 21 days cycles

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    750 mg/m2 on day1 of of R-CHOP regimen for six 21 days cycles

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/m2 of R-CHOP regimen for six 21 days cycles

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.3 mg/m2 (2mg dose max) on day 1 of R-CHOP regimen for six of 21 days cycles

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/m2 on days 1 -5 of R-Chop regimen for six 21 days cycles

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratracheal use
    Dosage and administration details
    50 mg on day 0 of cycles 2, 3, 4 and 5 of R-Chop 21 cycles

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 g/m2 Days 0 - 4 of two 14 days cycles

    Number of subjects in period 1
    		Arm 1
    Started
    54
    Completed
    45
    Not completed
    9
         Consent withdrawn by subject
    2
         Physician decision
    1
         Adverse event, non-fatal
    5
         Second malignancy
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis.

    Reporting group values
    		 Arm 1 Total
    Number of subjects
    		 54 54
    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)
    		 27 27
        From 65-84 years
    		 27 27
        85 years and over
    		 0 0
        Arm 1
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (37 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 54 54
    Ann Arbor Stage
    Units: Subjects
        Stage I
    		 32 32
        Stage II
    		 22 22
    Bilateral testicular location
    Units: Subjects
        Bilateral testicular location
    		 1 1
        No Bilateral testicular location
    		 53 53
    B symptoms
    Units: Subjects
        Presence of B symptoms
    		 2 2
        No presence of B symptoms
    		 52 52
    Serum lactate dehydrogenase (LDH)
    Units: Subjects
        > normal upper value
    		 7 7
        </= normal upper value
    		 47 47
    Serun Beta2-microglobulin
    Units: Subjects
        > normal upper value
    		 8 8
        </= normal upper value
    		 40 40
        Not recorded
    		 6 6
    Subject analysis sets

    Subject analysis set title
    R-CHOP + lyposomal cytarabine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects treated with R-CHOP (CHOP21)

    Subject analysis set title
    HD-MTX
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects treated with HD-MTX

    Subject analysis sets values
    		 R-CHOP + lyposomal cytarabine HD-MTX
    Number of subjects
    54
    48
    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)
    27
    26
        From 65-84 years
    27
    22
        85 years and over
    0
    0
        Arm 1
    54
    48
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    0
    0
        Male
    54
    48
    Ann Arbor Stage
    Units: Subjects
        Stage I
        Stage II
    Bilateral testicular location
    Units: Subjects
        Bilateral testicular location
        No Bilateral testicular location
    B symptoms
    Units: Subjects
        Presence of B symptoms
        No presence of B symptoms
    Serum lactate dehydrogenase (LDH)
    Units: Subjects
        > normal upper value
        </= normal upper value
    Serun Beta2-microglobulin
    Units: Subjects
        > normal upper value
        </= normal upper value
        Not recorded

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis.

    Subject analysis set title
    R-CHOP + lyposomal cytarabine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects treated with R-CHOP (CHOP21)

    Subject analysis set title
    HD-MTX
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects treated with HD-MTX

    Primary: Feasibility

    		 Close Top of page
    End point title
    		 Feasibility [1]
    End point description
    AEs causing withdrawal from study treatment
    End point type
    Primary
    End point timeframe
    From treatment start to the end of treatment
    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: No statistical analysis was planned or conducted for this endpoint
    End point values
    		 Arm 1 R-CHOP + lyposomal cytarabine HD-MTX
    Number of subjects analysed
    54
    54
    48
    Units: Subjects
        Subjects discontinuing treatment for toxicity
    6
    3
    3
    No statistical analyses for this end point

    Secondary: 5 year cumulative incidence of progression

    		 Close Top of page
    End point title
    		 5 year cumulative incidence of progression
    End point description
    Cumulative incidence of progression was measured from the date of achievement of a remission to the date of relapse until 5 years from study entry;
    End point type
    Secondary
    End point timeframe
    From the first documented response to relapse until 5 years from study entry
    End point values
    		 Arm 1
    Number of subjects analysed
    54
    Units: Percentage
        number (confidence interval 95%)
    6 (2 to 16)
    No statistical analyses for this end point

    Secondary: 5 years progression free survival (PFS)

    		 Close Top of page
    End point title
    		 5 years progression free survival (PFS)
    End point description
    PFS was meausered from time of study entry until lymphoma relapse/progression, or death because of any cause
    End point type
    Secondary
    End point timeframe
    From study entry until 5 years after
    End point values
    		 Arm 1
    Number of subjects analysed
    54
    Units: Percentage
        number (confidence interval 95%)
    91 (79 to 96)
    No statistical analyses for this end point

    Secondary: 5 years Overall survival (OS)

    		 Close Top of page
    End point title
    		 5 years Overall survival (OS)
    End point description
    OS was measured from study entry until the date of death from any cause
    End point type
    Secondary
    End point timeframe
    From study entry until 5 years after
    End point values
    		 Arm 1
    Number of subjects analysed
    54
    Units: Percentage
        number (confidence interval 95%)
    92 (81 to 97)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    From the date of informed consent signature until 30 days after the end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    5.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 All patients who have received at least one dose of treatment will be considered as Safety Population

    Reporting group title
    HD-MTX
    Reporting group description
    		 -

    Reporting group title
    R-CHOP + IT lyposomal cytarabine
    Reporting group description
    		 -

    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: The R-CHOP21 treatment was well tolerated, with no unexpected side effects and only a few AEs reported.
    Serious adverse events
    		 Safety population HD-MTX R-CHOP + IT lyposomal cytarabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 54 (35.19%)
    3 / 48 (6.25%)
    17 / 54 (31.48%)
         number of deaths (all causes)
    12
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Increase of neutrophilis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostatic Cancer
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac general pericardial effusion
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CNS cerebrovascular ischemia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial hemorrhage
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 48 (0.00%)
    4 / 54 (7.41%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Mucositis
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site reaction/extravasation changes
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pharyngitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute urinary retention
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 48 (0.00%)
    2 / 54 (3.70%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population HD-MTX R-CHOP + IT lyposomal cytarabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 54 (0.00%)

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2009
    The main purpose of this amendment was to revise the Schedule of Events, as the IT administration did not reflect what was stated in the previous protocol text. Additionally, a Steering Committee was included
    10 May 2010
    This amendment was implemented to remove certain hematology and blood chemistry evaluations and to correct some typographical errors.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 Aug 2012
    The trial was temporary halted due to a temporary withdrawal of Depocyte in the EU. Patients on treatment during trial suspension were treated with non liposomal ARA-C intra-tecal.
    19 Aug 2013

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 10 01:12:14 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA