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    Clinical Trial Results:
    Phase II multicenter study of extracorporeal photopheresis with UvadexTM plus standard steroid treatment for high risk acute Graft-versus-Host Disease

    Summary
    EudraCT number
    		 2019-000894-22
    Trial protocol
    		 DE   AT  
    Global end of trial date
    24 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2026
    First version publication date
    19 Jun 2026
    Other versions
    Summary report(s)
    		 MAGIC-HR-ECP-CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    MAGIC-HR-ECP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04291261
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Medical Center Hamburg-Eppendorf
    Sponsor organisation address
    Martinistrasse 52, Hamburg, Germany, 20246
    Public contact
    Francis A. Ayuk, Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf, 0049 40741055250, ayuketan@uke.de
    Scientific contact
    Francis A. Ayuk, Department of Stem Cell Transplantation - University Medical Center Hamburg-Eppendorf, 0049 40741055250, ayuketan@uke.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
    03 Mar 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to improve Day 28 GvHD complete response rate for Ann Arbor score 2 or 3 GvHD patients from the historical rate of 37% to 52% by treatment with ECP and high dose methylprednisolone (2 mg/kg) or equivalent dose prednisolone.
    Protection of trial subjects
    This study was conducted in accordance with applicable ICH/GCP regulations and guidelines, the general principles set forth in the Declaration of Helsinki, and all applicable regulatory requirements. Prior to the start of the study, the study protocol was reviewed and approved by an independent ethics committee (IEC). Prior to any study-related procedures, subjects were informed by a principal investigator about all procedures and counseled regarding the risks and benefits of the study. Patients were always given sufficient time to ask questions and decide whether they wished to participate in the study. Prior to any study-related procedures, written informed consent was obtained from the patients and the approving investigators.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Mar 2020
    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
    Austria: 1
    Country: Number of subjects enrolled
    Germany: 23
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    19
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 3 sites in Germany and 1 site in Austria. The sites were located at university hospitals with a focus on stem cell transplantation .

    Pre-assignment
    Screening details
    		 The screening process started after the patient was diagnosed with aGvHD (Glucksberg grade IIIV) following allogeneic SCT and after Informed Consent was collected. Sceening period time was Day -5 to Day 0. Patient eligibility was determined locally, except Ann Arbor scoring was measured centrally using standard technical procedures.

    Pre-assignment period milestones
    Number of subjects started
    		 52 [1]
    Number of subjects completed
    		 24

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Screening failures: 27
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Number started pre-assignment period are all screened patients. Number of worldwide enrolled are the patients who entered the trial for treatment (without screening failures).
    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
    		 ECP plus standard steroid treatment
    Arm description
    		 Days 0-56: ECP 3x/week in Week 1 and Week 2. 2x/week in Week 3 and Week 4, then once weekly until Day 56. Protocol treatment with ECP had to start within 5 working days (=7 days) after initiation of systemic steroid treatment for aGvHD. Dose of methylprednisolon 2 mg/kg/day orally or i.v. (or prednisone equivalent). The dose of steroids could not be tapered before 3 days of initiation of study therapy (=first ECP, defined as Day 0), but afterwards local institutional tapering practices could be followed. Weeks 10, 12 and Months 6, 9, 12: Follow-up Period. Patients were followed 1 year after removal from treatment or intil death, whichever accures first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    UVADEX
    Investigational medicinal product code
    Other name
    methoxsalen, 8-methoxypsoralen
    Pharmaceutical forms
    Solution for infusion in administration system
    Routes of administration
    Extracorporeal use
    Dosage and administration details
    UVADEX™ was supplied as a sterile solution containing methoxsalen 20 mcg, propylene glycol 50 mg, sodium chloride 8 mg, sodium acetate 1.75 mg, ethanol 40.550 mg, glacial acetic acid 1.260 mg, and water for injection q.s. to 1.0 mL. Glacial acetic acid and sodium hydroxide were used to adjust the pH of the solution if necessary. UVADEX™ was provided and distributed to the individual sites by Therakos (Mallinckrodt). The ECP procedure was be performed according to manufacturer’s guidelines. For the treatment, photopheresis consisted of removing a portion of the patient's blood and separating the red blood cells from the white cell layer (buffy coat) by centrifugation. The red cells were returned to the patient and the UVADEX™ sterile solution was then injected into the photopheresis system and mixed with the buffy coat. The instrument then irradiated this drug-cell mixture with ultraviolet light (UVA light, 320-400 nm) and returned the treated cells to the patient.

    Number of subjects in period 1
    		ECP plus standard steroid treatment
    Started
    24
    Completed
    21
    Not completed
    3
         Adverse event, serious fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 24 24
    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)
    		 19 19
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 14 14
    GvHD staging
    Units: Subjects
        Grade II
    		 17 17
        Grade III
    		 6 6
        Grade IV
    		 1 1
    Skin stages
    Units: Subjects
        No rash
    		 4 4
        Rash <25% BSA
    		 2 2
        Rash 25-50% BSA
    		 4 4
        > 50% generalized erythroderma
    		 14 14
    Liver stages
    Units: Subjects
        Bilirubin <2 mg/dl
    		 21 21
        Bilirubin 2.1-3 mg/dl
    		 2 2
        Bilirubin 3.1-6 mg/dl
    		 1 1
    Gastrointestinal tract
    Units: Subjects
        Diarrhea <500 ml/day
    		 10 10
        Diarrhea 500-1000 ml/day or severe nausea/vomiting
    		 8 8
        Diarrhea 1001-1500 ml/day
    		 4 4
        Diarrhea >1500 ml/day
    		 1 1
        severe abdominal pain with/without ileus, grossly
    		 1 1
    Diagnosis for transplantation
    Units: Subjects
        ALL
    		 2 2
        AML
    		 10 10
        CLL
    		 1 1
        CML
    		 1 1
        CMML
    		 1 1
        CMML-2
    		 1 1
        DLCL
    		 1 1
        Hodgkin's disease
    		 1 1
        MDS
    		 4 4
        MDS/MPN Overlap
    		 1 1
        OMF
    		 1 1
    Remission status at transplant
    Units: Subjects
        Aplasia
    		 1 1
        CR
    		 12 12
        PD
    		 2 2
        PR
    		 1 1
        Primary refractory
    		 1 1
        Relapse (after CR)
    		 1 1
        Untreated
    		 6 6
    Donor type
    Units: Subjects
        Related
    		 1 1
        Related (10/10)
    		 1 1
        Related (Haplo)
    		 2 2
        Related sibling (10/10)
    		 1 1
        Unrelated (10/10)
    		 14 14
        Unrelated (8/10)
    		 1 1
        Unrelated (8/8)
    		 1 1
        Unrelated (9/10)
    		 3 3
    Donor/recipient HLA-matching
    Units: Subjects
        Halfmatch
    		 1 1
        Match
    		 17 17
        Mismatch
    		 6 6
    GvHD prophylaxis (condensed)
    Units: Subjects
        CNI + MMF
    		 19 19
        CNI + MMF + PTCy
    		 5 5
    Ann Arbor Score
    Units: none
        median (inter-quartile range (Q1-Q3))
    		 2.0 (2.0 to 3.0) -
    Days since transplantation at enrollment
    Units: none
        median (inter-quartile range (Q1-Q3))
    		 20.0 (13.5 to 22.5) -
    HCT-CI score at transplant
    Units: none
        median (inter-quartile range (Q1-Q3))
    		 3.0 (3.0 to 6.0) -

    End points

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    End points reporting groups
    Reporting group title
    ECP plus standard steroid treatment
    Reporting group description
    		 Days 0-56: ECP 3x/week in Week 1 and Week 2. 2x/week in Week 3 and Week 4, then once weekly until Day 56. Protocol treatment with ECP had to start within 5 working days (=7 days) after initiation of systemic steroid treatment for aGvHD. Dose of methylprednisolon 2 mg/kg/day orally or i.v. (or prednisone equivalent). The dose of steroids could not be tapered before 3 days of initiation of study therapy (=first ECP, defined as Day 0), but afterwards local institutional tapering practices could be followed. Weeks 10, 12 and Months 6, 9, 12: Follow-up Period. Patients were followed 1 year after removal from treatment or intil death, whichever accures first.

    Primary: Complete response at Day 28 of study treatment

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    End point title
    		 Complete response at Day 28 of study treatment [1]
    End point description
    The primary endpoint was the proportion of CR at Day 28 of study treatment. Death, lack of CR at Day 28, or initiation of additional immunosuppressive therapy were considered failures for this endpoint. The following values show the proportion of CR together with a two-sided 90% exact Clopper-Pearson confidence interval (CI) and the p-value for the comparison with the historical rate of 0.37. p-value < 0.001: for testing the null hypothesis that the CR rate is smaller or equal to the historical rate a binomial test with a one-sided type I error rate of 5% was used.
    End point type
    Primary
    End point timeframe
    28 days after first ECP treatment (Day 0).
    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: Details are given in the description.
    End point values
    		 ECP plus standard steroid treatment
    Number of subjects analysed
    24 [2]
    Units: proportion
    number (confidence interval 90%)
        proportion of complete response (CR)
    0.8750 (0.7077 to 0.9650)
    Notes
    [2] - Full Analysis Set (FAS)
    No statistical analyses for this end point

    Secondary: Overall Response at Day 28

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    End point title
    		 Overall Response at Day 28
    End point description
    Pre-defined binary secondary endpoints were overall response at day 28 and 56, defined as CR or PR at day 28 and 56. Death, lack of CR/PR at the respective day or initiation of additional immunosuppressive therapy are considered as failures for this endpoint. The following values show the proportion of overall response at day 28 consisting of patients who achieved partial or complete response together with a two-sided 95% exact Wilson-Score CI.
    End point type
    Secondary
    End point timeframe
    Day 28 after first ECP treatment (Day 0)
    End point values
    		 ECP plus standard steroid treatment
    Number of subjects analysed
    24 [3]
    Units: proportion
    number (confidence interval 95%)
        Overall response at Day 28
    0.9167 (0.7415 to 0.9768)
    Notes
    [3] - Full analysis set
    No statistical analyses for this end point

    Secondary: Overall Response at Day 56

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    End point title
    		 Overall Response at Day 56
    End point description
    Pre-defined binary secondary endpoints were overall response at day 28 and 56, defined as CR or PR at day 28 and 56. Death, lack of CR/PR at the respective day or initiation of additional immunosuppressive therapy are considered as failures for this endpoint. The following values show the proportion of overall response at day 56 consisting of patients who achieved partial or complete response together with a two-sided 95% exact Wilson-Score CI.
    End point type
    Secondary
    End point timeframe
    Day 56 after first ECP treatment (Day 0)
    End point values
    		 ECP plus standard steroid treatment
    Number of subjects analysed
    23 [4]
    Units: proportion
    number (confidence interval 95%)
        Overall response at Day 56
    0.7826 (0.5810 to 0.9034)
    Notes
    [4] - Full analysis set
    No statistical analyses for this end point

    Secondary: Overall survival at 1 year

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    End point title
    		 Overall survival at 1 year
    End point description
    For the secondary endpoint overall survival (OS) at 1 year, an administrative censoring was applied at 1 year after enrollment, if patients are observed longer. The following table shows the estimates for 1-year OS together with the 95%-CI using Kaplan-Meier estimation.
    End point type
    Secondary
    End point timeframe
    1 year after enrollment
    End point values
    		 ECP plus standard steroid treatment
    Number of subjects analysed
    24 [5]
    Units: proportion
    number (confidence interval 95%)
        1-year OS
    0.875 (0.661 to 0.958)
    Notes
    [5] - Full analyis set
    No statistical analyses for this end point

    Secondary: Further time-to-event endpoints

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    End point title
    		 Further time-to-event endpoints
    End point description
    For all further time-to-event endpoints death (from any cause) was treated as competing event. The cumulative incidence at the respective timepoints was estimated using Aalen-Johansen estimators together with its 95%-CI. The following table shows the respective results.
    End point type
    Secondary
    End point timeframe
    6 months / 12 months /Visit Day 28 (visit window until 33 days) / Visit Days 56 ( window until 66 days)
    End point values
    		 ECP plus standard steroid treatment
    Number of subjects analysed
    24
    Units: Incidence
    number (confidence interval 95%)
        NRM (6 months)
    0.083 (0.014 to 0.233)
        NRM (12 months)
    0.083 (0.014 to 0.233)
        Chronic GvHD (12 months)
    0.5 (0.291 to 0.678)
        Severe GI aGvHD (6 months)
    0.083 (0.014 to 0.233)
        Treatment-refractory GvHD (Visit Day 28)
    0.042 (0.003 to 0.176)
        Treatment-refractory GvHD (Visit Day 56)
    0.219 (0.062 to 0.436)
    No statistical analyses for this end point

    Secondary: Safety endpoint - Relapse

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    End point title
    		 Safety endpoint - Relapse
    End point description
    The safety endpoints were analysed within the EFS population, which is equivalent to the FAS population. The following table shows the safety endpoint analysis for the endpoint "relapse" in the EFS/FAS population (Aalen-Johansen estimator).
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 ECP plus standard steroid treatment
    Number of subjects analysed
    24
    Units: Incidence
    number (confidence interval 95%)
        Relapse
    0.042 (0.003 to 0.176)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Data on all events meeting the criteria and defintion of an AE with CTCAE grade 3 or higher or SAE were collected from the time of consenting until the patient's follow-up phase .
    Adverse event reporting additional description
    For the Safety evaluation, AEs during treatment (defined at time of ECP treatment + 28 days) were used. Only events with CTCAE grade 3 , 4 and 5 (severe AEs and SAEs) were analysed.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28
    Reporting groups
    Reporting group title
    Adverse events - Safety population
    Reporting group description
    		 Subjects affected during treatment (defined as time of ECP treatment + 28 days) and with CTCAE grade ≥3.

    Serious adverse events
    		 Adverse events - Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 24 (58.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myopathy
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
    Additional description: unclear focus
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalivirus infection reactivation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Steroid diabetes
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adverse events - Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 24 (54.17%)
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Anaemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Infections and infestations
    Infections
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    4
    Sepsis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1

    More information

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    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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