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   43857   clinical trials with a EudraCT protocol, of which   7284   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 TO INVESTIGATE THE EFFICACY OF CYCLOPHOSPHAMIDE (ENDOXAN) AS SOLE GRAFT-VERSUS-HOST-PROPHYLAXIS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION (OCTET-CY)

    Summary
    EudraCT number
    		 2010-022058-18
    Trial protocol
    		 DE  
    Global end of trial date
    10 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2021
    First version publication date
    18 Sep 2021
    Other versions
    Summary report(s)
    		 Octet-Cy_summary_report
    PharmNet_results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Uni-Koeln-1430
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01283776
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany, 50923
    Public contact
    Dr. med. Udo Holtick, Dept. I of Internal Medicine Cologne University Hospital, University hospital Cologne , udo.holtick@uk-koeln.de
    Scientific contact
    Prof. C. Scheid Dept. I of Internal Medicine Cologne University Hospital, University hospital Cologne , christoph.scheid@uk-koeln.de
    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
    10 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of post-transplantation cyclophosphamide as single-agent GvHD prophylaxis after allogeneic hematopoietic stem cell transplantation in patients with multiple myeloma or lymphoma and to describe the influence of the modified immunosuppression concept on relapse rates, minimal residual disease, immune reconstitution and chimerism. Primary end point: • Number of patients not requiring any additional immunosuppressive treatment until day 100 after allogeneic transplantation
    Protection of trial subjects
    Patients will be treated according to current standard practices in the stem cell transplantation programme of the University Hospital Cologne. This includes prophylactic antibiotic, antifungal and antiviral agents. Corticosteroids are permitted in case of acute allergic reactions e.g. after transfusions. If an acute GvHD develops Corticosteroids and/or other immunosuppressive drugs such as calcineurin inhibitors may be used at the discretion of the treating physicians at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2011
    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
    Germany: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 moncentric trial, Germany; recruiting period March 2011 - August 2013

    Pre-assignment
    Screening details
    		 non screening has taken place. All patients included in the study fulfilled the inclusion cri-teria. No protocol deviations were recorded. All patients were considered for safety analysis.

    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
    		 allogeneic hematopoietic stem cell transplantation
    Arm description
    		 Patients received cyclophosphamide once daily (50mg/kg bodyweight) intravenous infusion on day +3 and +4 after standard allogeneic stem cell transplantation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Endoxan (trade name)
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50mg/kg bodyweight once daily intravenous infusion on days +3 and +4 after standard allogenic stem cell transplantation

    Number of subjects in period 1
    		allogeneic hematopoietic stem cell transplantation
    Started
    13
    Completed
    13

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Patients with multiple myeloma, Non-Hodgkin’s lymphoma or Hodgkin’s disease after allogeneic stem cell transplantation with reduced intensity conditioning

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 13 13
    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)
    		 13 13
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 10 10

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    allogeneic hematopoietic stem cell transplantation
    Reporting group description
    		 Patients received cyclophosphamide once daily (50mg/kg bodyweight) intravenous infusion on day +3 and +4 after standard allogeneic stem cell transplantation

    Primary: Number of patients not requiring any additional immuno-sup-pressive treatment until day 100 after allogeneic transplantation.

    		 Close Top of page
    End point title
    		 Number of patients not requiring any additional immuno-sup-pressive treatment until day 100 after allogeneic transplantation. [1]
    End point description
    Number of patients not requiring any additional immunosup-pressive treatment until day 100 after allogeneic transplantation. - As the main aim of this pilot study is to test post-transplant Cy as single-agent immunosuppression, the absence of systemic immunosuppression at d+100 has been defined as primary endpoint. It is measured as the proportion of patients not requring additional immunosuppressive treatment for GVHD until day 100.
    End point type
    Primary
    End point timeframe
    14.03.2011 – 10.08.2013
    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: see attached Summary report and publication reference
    End point values
    		 allogeneic hematopoietic stem cell transplantation
    Number of subjects analysed
    12
    Units: number of patients
        number of patients
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Advers events were collected from day +3 (beginning of IMP administration) until day 100 after transplantation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    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: For safety analysis see attached report summary

    More information

    		 Close Top of page

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25703164
    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-Thu Apr 25 01:22:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA