Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (LOTIS-2)
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ClinicalTrials.gov Identifier: NCT03589469 |
Recruitment Status :
Completed
First Posted : July 18, 2018
Results First Posted : July 29, 2021
Last Update Posted : August 29, 2023
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Sponsor:
ADC Therapeutics S.A.
Information provided by (Responsible Party):
ADC Therapeutics S.A.
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Diffuse Large B-Cell Lymphoma Refractory Diffuse Large B-cell Lymphoma Recurrent |
Intervention |
Drug: Loncastuximab tesirine |
Enrollment | 145 |
Participant Flow
Recruitment Details | Participants were enrolled at 28 study sites in Italy, Switzerland, the United Kingdom, and the United States from 01 August 2018 to 09 August 2022. |
Pre-assignment Details |
Arm/Group Title | Loncastuximab Tesirine |
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Arm/Group Description | Participants received loncastuximab tesirine as an intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg once every 3 weeks (Q3W) for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first. |
Period Title: Overall Study | |
Started | 145 |
Participants Received Treatment | 145 |
Completed | 11 |
Not Completed | 134 |
Reason Not Completed | |
Withdrawal by Subject | 8 |
Physician Decision | 20 |
Death | 97 |
Lost to Follow-up | 8 |
Miscellaneous | 1 |
Baseline Characteristics
Arm/Group Title | Loncastuximab Tesirine | |
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Arm/Group Description | Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first. | |
Overall Number of Baseline Participants | 145 | |
Baseline Analysis Population Description |
All-treated population - all participants who received at least 1 dose of treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 145 participants | |
62.7 (13.63) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | |
Female |
60 41.4%
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Male |
85 58.6%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 145 participants | |
Hispanic or Latino |
13 9.0%
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Not Hispanic or Latino |
132 91.0%
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Unknown or Not Reported |
0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race | Number Analyzed | 145 participants |
White |
130 89.7%
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Black or African American |
5 3.4%
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Asian |
3 2.1%
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American Indian or Alaskan Native |
1 0.7%
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Native Hawaiian or Pacific Islander |
1 0.7%
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Other |
5 3.4%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 145 participants |
United States |
59 40.7%
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United Kingdom |
31 21.4%
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Italy |
53 36.6%
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Switzerland |
2 1.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
PI can publish after first multi-site publication or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on PI is sponsor can review results comms. prior to public release and can embargo comms. regarding trial results for a period >60 but ≤180 days from time submitted to sponsor review. Sponsor can't require changes to the comms, extend embargo or require changes to comms, except removing confidential info that are not results
Results Point of Contact
Name/Title: | Clinical Trials Information |
Organization: | ADC Therapeutics SA |
Phone: | 954-903-7994 ext 954 |
EMail: | clinical.trials@adctherapeutics.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ADC Therapeutics S.A. |
ClinicalTrials.gov Identifier: | NCT03589469 |
Other Study ID Numbers: |
ADCT-402-201 2017-004288-11 ( EudraCT Number ) |
First Submitted: | May 4, 2018 |
First Posted: | July 18, 2018 |
Results First Submitted: | May 20, 2021 |
Results First Posted: | July 29, 2021 |
Last Update Posted: | August 29, 2023 |