B-Cell LymphomasNCT05160064
Long-term Registry of Patients Treated With Loncastuximab Tesirine
An observational study of B-Cell Lymphomas, run by ADC Therapeutics S.A. at 1 site in United States.
Trial summary
Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphomas
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2022to Jan 2025
- How long will I take part?
- 48 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients initiated or initiating commercially available loncastuximab tesirine treatment.
Who may be able to join
- Must be ≥ 18 years of age at the time of consent.
- Initiated or initiating commercially available loncastuximab tesirine treatment.
- Written informed consent must be obtained prior to any registry activities.
Who cannot join
- Prior loncastuximab tesirine exposure in clinical trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
Compassionate Cancer Care Medical Group
Fountain Valley, California, 92708
About this study
Official title: Long-term Longitudinal Cohort Registry of Patients Treated With Loncastuximab Tesirine
Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.
Read the detailed description
The purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
- Conditions
- B-Cell Lymphomas
- Keywords
- Diffuse Large B-Cell Lymphoma, Loncastuximab tesirine, Non-Hodgkin Lymphoma, Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated with Loncastuximab Tesirine | Patients with B-cell lymphomas and other diagnoses who have been treated with loncastuximab tesirine will have their medical chart data entered into the registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: Up to 48 Months
Overall Survival (OS)
Measured: Up to 48 Months
Duration of Response (DoR)
Measured: Up to 48 Months
Overall Response Rate (ORR)
Measured: Up to 48 Months
Time to Partial Response (PR)
Measured: Up to 48 Months
Time to Complete Response (CR)
Measured: Up to 48 Months
Time to Disease Progression
Measured: Up to 48 Months
Number of Patients with Adverse Events
Includes serious adverse events (SAEs) and adverse events (AEs) Grade 3 or higher for the events of: edema, myelosuppression, infections, and cutaneous reactions.
Measured: Up to 48 Months
Secondary outcomes (10)
Number of Hospitalizations
Measured: Up to 48 Months
Duration of Hospitalizations
Measured: Up to 48 Months
Reasons for Hospitalizations
Measured: Up to 48 Months
Number of Surgeries
Measured: Up to 48 Months
Type of Surgeries
Measured: Up to 48 Months
Reasons for Surgeries
Measured: Up to 48 Months
Number of Emergency Room Visits
Measured: Up to 48 Months
Reasons for Emergency Room Visits
Measured: Up to 48 Months
Number of Outpatient Visits
Measured: Up to 48 Months
Reasons for Outpatient Visits
Measured: Up to 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start30 Jun 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Sponsor administrative decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- ADC Therapeutics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160064
- Sponsor's protocol ID
- ADCT-402-N01
- Status last verified
- Jun 2022
- First submitted
- 3 Dec 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Longitudinal Cohort Registry of Patients Treated With Loncastuximab Tesirine
- ClinicalTrials.gov ID
- NCT05160064
- Acronym / sponsor ID
- ADCT-402-N01
- Conditions
- B-Cell Lymphomas
- Keywords
- Diffuse Large B-Cell Lymphoma, Loncastuximab tesirine, Non-Hodgkin Lymphoma, Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor administrative decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ADC Therapeutics S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.
Detailed description
The purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated with Loncastuximab Tesirine | – | –Patients with B-cell lymphomas and other diagnoses who have been treated with loncastuximab tesirine will have their medical chart data entered into the registry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients initiated or initiating commercially available loncastuximab tesirine treatment.
Key inclusion criteria (3 listed)
- Must be ≥ 18 years of age at the time of consent.
- Initiated or initiating commercially available loncastuximab tesirine treatment.
- Written informed consent must be obtained prior to any registry activities.
Key exclusion criteria (1 listed)
- Prior loncastuximab tesirine exposure in clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free Survival (PFS)
Time frame: Up to 48 Months
Overall Survival (OS)
Time frame: Up to 48 Months
Duration of Response (DoR)
Time frame: Up to 48 Months
Overall Response Rate (ORR)
Time frame: Up to 48 Months
Time to Partial Response (PR)
Time frame: Up to 48 Months
Time to Complete Response (CR)
Time frame: Up to 48 Months
Time to Disease Progression
Time frame: Up to 48 Months
Number of Patients with Adverse Events
Time frame: Up to 48 Months
Includes serious adverse events (SAEs) and adverse events (AEs) Grade 3 or higher for the events of: edema, myelosuppression, infections, and cutaneous reactions.
10 secondary outcomes
Number of Hospitalizations
Time frame: Up to 48 Months
Duration of Hospitalizations
Time frame: Up to 48 Months
Reasons for Hospitalizations
Time frame: Up to 48 Months
Number of Surgeries
Time frame: Up to 48 Months
Type of Surgeries
Time frame: Up to 48 Months
Reasons for Surgeries
Time frame: Up to 48 Months
Number of Emergency Room Visits
Time frame: Up to 48 Months
Reasons for Emergency Room Visits
Time frame: Up to 48 Months
Number of Outpatient Visits
Time frame: Up to 48 Months
Reasons for Outpatient Visits
Time frame: Up to 48 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-Cell Lymphomas, run by ADC Therapeutics S.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Up to 48 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.