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    Clinical Trial Results:
    Clofarabine salvage therapy in patients with relapsed or refractory AML The BRIDGE Trial

    Summary
    EudraCT number
    		 2010-022584-35
    Trial protocol
    		 DE  
    Global end of trial date
    23 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2021
    First version publication date
    01 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TUD-BRIDGE-046
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01295307
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität Dresden
    Sponsor organisation address
    Mommsenstr. 9, Dresden, Germany,
    Public contact
    Head of Clinical Trials Unit, Universitätsklinikum Dresden, Med. Klinik und Poliklinik I, +49 351458-3775, christoph.roellig@uniklinikum-dresden.de
    Scientific contact
    Head of Clinical Trials Unit, Universitätsklinikum Dresden, Med. Klinik und Poliklinik I, +49 351458-3775, christoph.roellig@uniklinikum-dresden.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
    09 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the safety and efficacy of clofarabine salvage therapy prior to allogeneic HCT. (Rate of treatment success)
    Protection of trial subjects
    In the responsibility of the investigator, subjects were closely monitored during this study. Via the safety desk, the coordinating investigator on behalf of the sponsor reviewed all reported SAEs for reasonable suspected causal relationship to the investigational treatment and for expectedness in terms of nature and severity of an SAR in relation to the applicable clofarabine product information or investigator’s brochure.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2010
    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: 84
    Worldwide total number of subjects
    84
    EEA total number of subjects
    84
    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)
    56
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between March 2011 and May 2013, 84 pts with relapsed or refractory AML older than 40 years were enrolled.

    Pre-assignment
    Screening details
    		 Pretreatment evaluations were done to determine the patients eligibility for the study within 14 days prior to study inclusion.

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

    Arms
    Arm title
    		 CLARA
    Arm description
    		 Pts were scheduled for at least one cycle of induction therapy with CLARA (clofarabine 30 mg/m2 and cytarabine 1 g/m2 days 1-5). Pts with a donor received HSCT in aplasia after first CLARA. In case of a prolonged donor search HSCT was performed as soon as possible. Consolidation therapy contained clofarabine 30 mg/m2 (1 hr IV infusion) days 1-4 followed 3 hours after the end of infusion by intermediate dose cytarabine 1 g/m2 (2 hrs IV infusion) days 1-4. The conditioning regimen consisted of clofarabine 30 mg/m2 day -6 to -3 and melphalan 140 mg/m2 on day -2. In pts with partially matched unrelated donors ATG (Genzyme) at a cumulative dose of 4.5 mg/kg was recommended.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clofarabine
    Investigational medicinal product code
    Other name
    CAS: 123318-82-1
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction: clofarabine 30 mg/m2 (1 hr IV infusion) days 1-5 Re-Induction: clofarabine 30 mg/m2 (1 hr IV infusion) days 1-5 Consolidation: clofarabine 30 mg/m2 (1 hr IV infusion) days 1-4 Conditioning: clofarabine 30 mg/m2 (1 hr IV infusion) days –6 to –3

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    CAS: 147-94-4
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction: cytarabine 1 g/m2 (2 hrs IV infusion) days 1-5 Re-Induction: cytarabine 1 g/m2 (2 hrs IV infusion) days 1-5 Consolidation: cytarabine 1 g/m2 (2 hrs IV infusion) days 1-4

    Number of subjects in period 1
    		CLARA
    Started
    84
    Completed
    67
    Not completed
    17
         Adverse event, serious fatal
    13
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Patients with relapsed or refractory AML older than 40 years

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 84 84
    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)
    		 56 56
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 51 51

    End points

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    End points reporting groups
    Reporting group title
    CLARA
    Reporting group description
    		 Pts were scheduled for at least one cycle of induction therapy with CLARA (clofarabine 30 mg/m2 and cytarabine 1 g/m2 days 1-5). Pts with a donor received HSCT in aplasia after first CLARA. In case of a prolonged donor search HSCT was performed as soon as possible. Consolidation therapy contained clofarabine 30 mg/m2 (1 hr IV infusion) days 1-4 followed 3 hours after the end of infusion by intermediate dose cytarabine 1 g/m2 (2 hrs IV infusion) days 1-4. The conditioning regimen consisted of clofarabine 30 mg/m2 day -6 to -3 and melphalan 140 mg/m2 on day -2. In pts with partially matched unrelated donors ATG (Genzyme) at a cumulative dose of 4.5 mg/kg was recommended.

    Primary: rate of treatment success

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    End point title
    		 rate of treatment success [1]
    End point description
    This rate was assessed in the intent-to-treat population. The rate of treatment success was analyzed in an optimal two-stage design according to Simon.
    End point type
    Primary
    End point timeframe
    The primary endpoint, treatment success, was defined as complete remission (CR), CR with incomplete recovery (CRi) or CRchim (BM donor chimerism >95% and absolute neutrophil count >0.5/nL) on day 35 after HSCT.
    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: More detailed description available (see online references)
    End point values
    		 CLARA
    Number of subjects analysed
    84
    Units: percent
    number (confidence interval 95%)
        rate of treatment success
    61 (50 to 70)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were reported after intake of the first dose of study medication.
    Adverse event reporting additional description
    Adverse events of special interest of any grade All adverse events CTCAE grade ≥3
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Frequency threshold for reporting non-serious adverse events: 5%
    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: More detailed description available (see online references)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2011
    protocol amendment: The interval for investigations had been refined. Prompted by a report on preliminary results of CLARA chemotherapy the starting dose level has been reduced.

    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/26283567
    http://www.ncbi.nlm.nih.gov/pubmed/28527985
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