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Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

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