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

NCT ID: NCT04705454

Last Updated: 2021-05-12

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)

Interventions

Loncastuximab Tesirine

Intervention Type: BIOLOGICAL

Other Intervention Names

Zynlonta

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADC Therapeutics S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ADCT-402 EAP

Identifier Type: -

Identifier Source: org_study_id