| Eligibility |
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
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