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 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma (LOTIS 6)

    Summary
    EudraCT number
    		 2020-003695-40
    Trial protocol
    		 BE   PL   HU   IT   ES  
    Global end of trial date
    25 Nov 2022

    Results information
    Results version number
    		 v1
    This version publication date
    09 Sep 2023
    First version publication date
    09 Sep 2023
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ADCT-402-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04699461
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: 126138
    Sponsors
    Sponsor organisation name
    ADC Therapeutics SA
    Sponsor organisation address
    Route de la Corniche, 3B, Epalinges, Switzerland, 1066
    Public contact
    Clinical Trials Information, ADC Therapeutics SA, clinicaltrials@adctherapeutics.com
    Scientific contact
    Clinical Trials Information, ADC Therapeutics SA, clinicaltrials@adctherapeutics.com
    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
    25 Nov 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of single agent loncastuximab tesirine compared to idelalisib in participants with relapsed or refractory follicular lymphoma.
    Protection of trial subjects
    The study was performed in accordance with the protocol and with the Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2021
    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
    Spain: 2
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Poland: 2
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    5
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at research centers in Spain, Hungary and Poland from November 2021 to November 2022. Only 6 participants were enrolled and the study was terminated early (administrative decision).

    Pre-assignment
    Screening details
    		 Eligible participants were randomly assigned in a 2:1 ratio to treatment with loncastuximab tesirine or idelalisib.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Loncastuximab Tesirine
    Arm description
    		 Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine was administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles. The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loncastuximab Tesirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV infusion on Day 1 of each cycle. Loncastuximab tesirine was administered at 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles.

    Arm title
    		 Idelalisib
    Arm description
    		 Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks. 1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Idelalisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg orally, twice a day on Day 1 of each cycle.

    Number of subjects in period 1
    		Loncastuximab Tesirine Idelalisib
    Started
    4
    2
    Completed
    0
    0
    Not completed
    4
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    -
         Radiographic progression
    -
    1
         Study termination by sponsor
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        Age 55 to 69 years
    		 6 6
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (55 to 69) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 2 2

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Loncastuximab Tesirine
    Reporting group description
    		 Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine was administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles. The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).

    Reporting group title
    Idelalisib
    Reporting group description
    		 Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks. 1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.

    Primary: Complete Response Rate (CRR)

    		 Close Top of page
    End point title
    		 Complete Response Rate (CRR) [1]
    End point description
    CRR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR) assessed prior to any subsequent anticancer treatment. Due to the limited number of participants enrolled and completing the study, no summary statistics could be calculated.
    End point type
    Primary
    End point timeframe
    Up to the end of treatment, maximum time on treatment was 333 days
    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 formal statistical analysis was planned.
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [2] - Insufficient number of participants experienced CR, so CRR could not be calculated.
    [3] - Insufficient number of participants experienced CR, so CRR could not be calculated.
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

    		 Close Top of page
    End point title
    		 Overall Response Rate (ORR)
    End point description
    ORR was defined as the percentage of participants with a BOR of CR or partial response (PR) assessed prior to any subsequent anticancer treatment. Due to the limited number of participants enrolled and completing the study, no summary statistics could be calculated.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [4] - Insufficient number of participants experienced CR or PR, so ORR could not be calculated.
    [5] - Insufficient number of participants experienced CR or PR, so ORR could not be calculated.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS was defined as the time between the randomization date and the first documentation of recurrence, progression, or death. Due to the limited number of participants enrolled and completing the study, no summary statistics could be calculated.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Days
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [6] - Insufficient number of participants had recurrence, progression, or death, PFS could not calculated.
    [7] - Insufficient number of participants had recurrence, progression, or death, PFS could not calculated.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time between the randomization date and death from any cause. Due to the limited number of participants enrolled and completing the study, no summary statistics could be calculated.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Days
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [8] - Insufficient number of participants experienced death, so OS could not be calculated.
    [9] - Insufficient number of participants experienced death, so OS could not be calculated.
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

    		 Close Top of page
    End point title
    		 Duration of Response (DOR)
    End point description
    DOR was defined as the time from the documentation of tumor response to disease progression or death. Due to the limited number of participants enrolled and completing the study, no summary statistics could be calculated.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Days
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [10] - Insufficient number of participants had progression or death, so DOR could not be calculated.
    [11] - Insufficient number of participants had progression or death, so DOR could not be calculated.
    No statistical analyses for this end point

    Secondary: Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)

    		 Close Top of page
    End point title
    		 Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
    End point description
    TEAEs were defined as an AE that occurs or worsens in the period extending from the first dose of study treatment until 30 days after the last dose of study treatment or start of new anti-cancer therapy, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
    End point type
    Secondary
    End point timeframe
    Day 1 to 30 days after end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    4
    2
    Units: Participants
        TEAEs
    4
    2
        Serious TEAEs
    3
    0
    No statistical analyses for this end point

    Secondary: Average Concentration of Loncastuximab Tesirine Before Infusion

    		 Close Top of page
    End point title
    		 Average Concentration of Loncastuximab Tesirine Before Infusion
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [12] - No summary statistics could be collected.
    [13] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Average Concentration of Loncastuximab Tesirine at the End of Infusion

    		 Close Top of page
    End point title
    		 Average Concentration of Loncastuximab Tesirine at the End of Infusion
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [14] - No summary statistics could be collected.
    [15] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Clearance Rate of Loncastuximab Tesirine

    		 Close Top of page
    End point title
    		 Clearance Rate of Loncastuximab Tesirine
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: Litres/hour
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [16] - No summary statistics could be collected.
    [17] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Volume of Distribution of Loncastuximab Tesirine

    		 Close Top of page
    End point title
    		 Volume of Distribution of Loncastuximab Tesirine
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: Litres
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [18] - No summary statistics could be collected.
    [19] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine

    		 Close Top of page
    End point title
    		 Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Participants
    Notes
    [20] - No summary statistics could be collected.
    [21] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

    		 Close Top of page
    End point title
    		 Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [22] - No summary statistics could be collected.
    [23] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

    		 Close Top of page
    End point title
    		 Change From Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
    End point description
    Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [24] - No summary statistics could be collected.
    [25] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Number of Participants With Specific Symptomatic Adverse Event Symptoms As Selected From Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    		 Close Top of page
    End point title
    		 Number of Participants With Specific Symptomatic Adverse Event Symptoms As Selected From Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
    End point description
    The specific symptomatic adverse events includes fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough. Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: Participants
    Notes
    [26] - No summary statistics could be collected.
    [27] - No summary statistics could be collected.
    No statistical analyses for this end point

    Secondary: Treatment-Related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    		 Close Top of page
    End point title
    		 Treatment-Related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
    End point description
    The specific symptoms assessed include fatigue, swelling, rash, nausea, diarrhea, abdominal pain, and cough. The severity is assessed from "None" to "Very severe" and the interference level is assessed from "Not at all" to "Very much." Due to the limited number of participants enrolled and completing the study, no data for summary statistics could be collected.
    End point type
    Secondary
    End point timeframe
    Up to end of treatment, maximum time on treatment was 333 days
    End point values
    		 Loncastuximab Tesirine Idelalisib
    Number of subjects analysed
    0 [28]
    0 [29]
    Units: Participants
    Notes
    [28] - No summary statistics could be collected.
    [29] - No summary statistics could be collected.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to end of treatment, maximum time on treatment was 333 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Loncastuximab Tesirine
    Reporting group description
    		 Participants were administered loncastuximab tesirine as an intravenous (IV) infusion on Day 1 of each cycle, where 1 cycle is 3 weeks. Loncastuximab tesirine was administered at a dose of 150 μg/kg for 2 cycles, then at a dose of 75 μg/kg for subsequent cycles. The median number of treatment cycles was 5.5 (min: 5; max: 12). The median treatment duration was 122.5 days (min: 54; max: 231 days).

    Reporting group title
    Idelalisib
    Reporting group description
    		 Participants were administered 150 mg idelalisib, orally, twice a day throughout each cycle, where 1 cycle is 4 weeks. 1 participant received 6 cycles and the other participant received 13 cycles of treatment. The treatment duration was 140 days and 333 days, respectively.

    Serious adverse events
    		 Loncastuximab Tesirine Idelalisib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Loncastuximab Tesirine Idelalisib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    2 / 2 (100.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 2 (100.00%)
         occurrences all number
    1
    6
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 2 (100.00%)
         occurrences all number
    2
    5
    Blood creatinine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Lipase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Neutropenia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Odynophagia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Porphyria non-acute
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Seborrheic keratosis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19 infection
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    COVID-19 pneumonia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Nov 2020
    The primary reason for Protocol Amendment 1 was to incorporate the changes in response to the US FDA feedback. This amendment combines changes regarding safety monitoring, study stratification, and statistical analysis. In addition, updates include removal of QTcF eligibility criteria and dexamethasone equivalent as premedication, assigning ORR as key secondary endpoint, as well as modifications on PRO schedules.
    19 Feb 2021
    The primary reason for Protocol Amendment 2 was to extend the contraception duration post loncastuximab tesirine for female participants with childbearing potential from 6 to 9 months to align with current regulatory guidance.
    07 Apr 2021
    The primary reason for Protocol Amendment 3 is to align the frequency of laboratory evaluations for participants treated with idelalisib with the idelalisib Summary of Product Characteristics (SmPC); to exclude participants with history of hypersensitivity to any of the excipients of study drugs; to align contraception guidance for women of childbearing potential (WOCBP) receiving idelalisib treatment with the idelalisib SmPC; and to extend SAE reporting duration to at least 5 half-lives after the last loncastuximab tesirine dose based on regulatory authority request.

    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.
    The study was terminated due to administrative decision (not due to safety reason) by the sponsor following the withdrawal of idelalisib from the US market for the relapsed FL indication (i.e., not due to any safety reasons emerging from this study).
    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 11:45:31 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA