Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Primary Purpose
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Loncastuximab Tesirine
Sponsored by
About this trial
This is an expanded access trial for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) focused on measuring Expanded Access, Lymphoma, Large B-Cell, Relapsed, Refractory
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04705454
Brief Title
Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADC Therapeutics S.A.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
Keywords
Expanded Access, Lymphoma, Large B-Cell, Relapsed, Refractory
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Loncastuximab Tesirine
Other Intervention Name(s)
Zynlonta
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
12. IPD Sharing Statement
Learn more about this trial
Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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