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

NCT04705454 | Unknown

• 1 other identifier: ADCT-402 EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Expanded Access; Lymphoma; Large B-Cell; Relapsed; Refractory

Interventions

Loncastuximab Tesirine BIOLOGICAL

Also known as: Zynlonta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• ADC Therapeutics S.A.: lead

MeSH Terms

Conditions

Recurrence; Lymphoma, Large B-Cell, Diffuse; Lymphoma

Interventions

loncastuximab tesirine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05