Studies
| Study First Submitted Date | 2021-01-08 |
| Study First Posted Date | 2021-01-12 |
| Last Update Posted Date | 2021-05-12 |
| Verification Month Year | May 2021 |
| Verification Date | 2021-05-31 |
| Last Update Posted Date | 2021-05-12 |
Browse Interventions
| Sequence: | 95551585 | Sequence: | 95551586 | Sequence: | 95551587 |
| Mesh Term | Loncastuximab tesirine | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Antineoplastic Agents |
| Downcase Mesh Term | loncastuximab tesirine | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | antineoplastic agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 51914319 |
| Name | Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) |
| Downcase Name | relapsed or refractory diffuse large b-cell lymphoma (r/r dlbcl) |
Id Information
| Sequence: | 39957257 |
| Id Source | org_study_id |
| Id Value | ADCT-402 EAP |
Interventions
| Sequence: | 52228635 |
| Intervention Type | Biological |
| Name | Loncastuximab Tesirine |
Keywords
| Sequence: | 79460374 | Sequence: | 79460375 | Sequence: | 79460376 | Sequence: | 79460377 | Sequence: | 79460378 |
| Name | Expanded Access | Name | Lymphoma | Name | Large B-Cell | Name | Relapsed | Name | Refractory |
| Downcase Name | expanded access | Downcase Name | lymphoma | Downcase Name | large b-cell | Downcase Name | relapsed | Downcase Name | refractory |
Browse Conditions
| Sequence: | 192454956 | Sequence: | 192454957 | Sequence: | 192454958 | Sequence: | 192454959 | Sequence: | 192454960 | Sequence: | 192454961 | Sequence: | 192454962 | Sequence: | 192454963 | Sequence: | 192454964 | Sequence: | 192454965 |
| Mesh Term | Lymphoma | Mesh Term | Lymphoma, B-Cell | Mesh Term | Lymphoma, Large B-Cell, Diffuse | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Lymphoma, Non-Hodgkin |
| Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoma, b-cell | Downcase Mesh Term | lymphoma, large b-cell, diffuse | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | lymphoma, non-hodgkin |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48077384 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | ADC Therapeutics S.A. |
Eligibilities
| Sequence: | 30612732 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253959529 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Intervention Other Names
| Sequence: | 26548115 |
| Intervention Id | 52228635 |
| Name | Zynlonta |
Responsible Parties
| Sequence: | 28731499 |
| Responsible Party Type | Sponsor |