Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)NCT04705454
Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A study testing Loncastuximab Tesirine in people with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL), run by ADC Therapeutics S.A..
Trial summary
The EAP is for patients with relapsed/refractory diffuse large b-cell lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials. ADC Therapeutics will evaluate patients for approval into the program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
- What is being tested?
- Loncastuximab Tesirine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Male or female patient aged 18 years or older
- Pathologic diagnosis of DLBCL
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials
- Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least six months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least six months after the patient receives his last dose of loncastuximab tesirine
Who cannot join
- Known history of hypersensitivity to or positive serum human Anti-Drug Antibodies to loncastuximab tesirine
- Total bilirubin >1.5 x upper limit of normal (ULN)
- Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that ADCT Head of Medical Affairs and/or designee, and treating physician agree and document should not be exclusionary
- Autologous Stem Cell Transplantation (SCT) within 30 days prior to start of loncastuximab tesirine
- Allogeneic SCT within 60 days prior to start of loncastuximab tesirine
- Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
Show all 11Show fewer
- Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease
- Breastfeeding or pregnant
- Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to starting loncastuximab tesirine, except shorter if approved by ADCT
- Use of any other experimental medication within 14 days prior to starting loncastuximab tesirine
- Any other significant medical illness, abnormality, or condition that would, in the treating physician's judgment, make the patient inappropriate to receive loncastuximab tesirine or put the patient at risk
About this study
The EAP is for patients with relapsed/refractory diffuse large b-cell lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials. ADC Therapeutics will evaluate patients for approval into the program.
- Being tested
- Loncastuximab Tesirine
- Keywords
- Expanded Access, Lymphoma, Large B-Cell, Relapsed, Refractory
- Medical subject headings
- Recurrence, Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab TesirineBiological
Also called Zynlonta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)Studies 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
- Expanded access
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
- NCT04705454
- Sponsor's protocol ID
- ADCT-402 EAP
- Status last verified
- May 2021
- First submitted
- 8 Jan 2021
- Last updated
- 12 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04705454
- Acronym / sponsor ID
- ADCT-402 EAP
- Keywords
- Expanded Access, Lymphoma, Large B-Cell, Relapsed, Refractory
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ADC Therapeutics S.A.Industry (pharma, biotech, devices)
- First posted
- 12 Jan 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.
The EAP is for patients with relapsed/refractory diffuse large b-cell lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials. ADC Therapeutics will evaluate patients for approval into the program.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patient aged 18 years or older
- Pathologic diagnosis of DLBCL
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials
- Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least six months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least six months after the patient receives his last dose of loncastuximab tesirine
Key exclusion criteria (11 listed)
- Known history of hypersensitivity to or positive serum human Anti-Drug Antibodies to loncastuximab tesirine
- Total bilirubin >1.5 x upper limit of normal (ULN)
- Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that ADCT Head of Medical Affairs and/or designee, and treating physician agree and document should not be exclusionary
- Autologous Stem Cell Transplantation (SCT) within 30 days prior to start of loncastuximab tesirine
- Allogeneic SCT within 60 days prior to start of loncastuximab tesirine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loncastuximab TesirineAlso: Zynlonta | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
Related trials for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
RecruitingPhase 2
Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL
Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma
Not yet recruitingObservational study
A Study to Assess Change in Disease State and Adverse Events in Korean Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Receiving Epcoritamab Injections
Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 2/3
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Relapsed/Refractory Diffuse Large B-cell Lymphoma
Active, not recruitingPhase 3
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
DLBCL
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.
Questions about this trial
What is this clinical trial studying?
A study testing Loncastuximab Tesirine in people with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL), run by ADC Therapeutics S.A..
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 12 May 2021.