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

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ClinicalTrials.gov Identifier: NCT04705454
Expanded Access Status : Available
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
ADC Therapeutics S.A.

Study Description
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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.

Condition or disease Intervention/treatment
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) Biological: Loncastuximab Tesirine

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Interventions
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705454


Contacts
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Contact: ADC Therapeutics Medical Affairs (954) 903-7994 eap@adctherapeutics.com

Sponsors and Collaborators
ADC Therapeutics S.A.
More Information
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Responsible Party: ADC Therapeutics S.A.
ClinicalTrials.gov Identifier: NCT04705454    
Other Study ID Numbers: ADCT-402 EAP
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Keywords provided by ADC Therapeutics S.A.:
Expanded Access
Lymphoma
Large B-Cell
Relapsed
Refractory
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin