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

Primary Purpose

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

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Loncastuximab Tesirine
Sponsored by
ADC Therapeutics S.A.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) focused on measuring Expanded Access, Lymphoma, Large B-Cell, Relapsed, Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2021
    Last Updated
    May 10, 2021
    Sponsor
    ADC Therapeutics S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04705454
    Brief Title
    Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ADC Therapeutics S.A.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
    Keywords
    Expanded Access, Lymphoma, Large B-Cell, Relapsed, Refractory

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Loncastuximab Tesirine
    Other Intervention Name(s)
    Zynlonta

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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