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A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8) (LOTIS-8)

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Loncastuximab tesirine
Prednisone
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Sponsored by
ADC Therapeutics S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma, Untreated Diffuse Large B-Cell Lymphoma, DLBCL, Loncastuximab Tesirine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent must be obtained prior to any study procedures
  2. Male or female participant aged 18 years or older
  3. Pathologic diagnosis of diffuse large B-cell lymphoma (DLBCL), as defined by the 2016 World Health Organization classification (including participants with DLBCL transformed from indolent lymphoma), or high-grade B cell lymphoma
  4. Measurable disease as defined by the 2014 Lugano Classification
  5. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue sample. (If tissue block is not available, slides from a FFPE block may be acceptable for eligibility upon consultation with the Sponsor)
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  7. Adequate organ function as defined by screening laboratory values within the following parameters:

    1. Absolute neutrophil count ≥1.5 × 10^3/μL (off growth factors at least 72 hours)
    2. Platelet count ≥75 × 10^3/μL without transfusion in the past 7 days
    3. Hemoglobin ≥9 g/dL (4.96 mmol/L), transfusion allowed
    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN)
    5. Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN)
    6. Calculated creatinine clearance >30 mL/min by the Cockcroft and Gault equation

    Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.

  8. Left ventricular ejection fraction (LVEF) of ≥50%, assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan
  9. Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the last dose of study drug.

Women of childbearing potential are defined as sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (i.e., who have not menstruated at all) for at least one year. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective forms of birth control include: hormonal contraceptives (oral, injectable, patch, intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the participant.

Note: The double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide-only are not acceptable as highly effective methods of contraception.

Exclusion Criteria:

  1. Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a cluster of differentiation 19 (CD19) antibody
  2. Previous therapy with loncastuximab tesirine, rituximab, anthracycline, or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)
  3. Known history of hypersensitivity to any component of study treatment (loncastuximab tesirine and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP])
  4. Previous treatment for aggressive lymphoma (with exception of short corticosteroid course [up to 7 days] for symptom management)
  5. Contraindication to receive granulocyte colony stimulating factors
  6. Human immunodeficiency virus (HIV) seropositive with any of the following:

    1. Cluster of differentiation 4 (CD4) + T-cell (CD4+) counts <350 cells/μL
    2. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
    3. Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of Screening
    4. HIV viral load ≥400 copies/mL
  7. Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
  8. Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
  9. History of Stevens-Johnson syndrome or toxic epidermal necrolysis
  10. Lymphoma with active central nervous system involvement at the time of Screening, including leptomeningeal disease
  11. 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)
  12. Breastfeeding or pregnant
  13. Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to Screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
  14. Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at the time of Screening
  15. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1 [C1D1]; cycle is 21 days), except shorter if approved by the Sponsor
  16. Use of any other experimental medication within 14 days prior to start of study drug (C1D1; cycle is 21 days)
  17. Received live vaccine within 4 weeks of C1D1; cycle is 21 days
  18. Congenital long measure between Q wave and T wave in the electrocardiogram (QT) syndrome or a corrected Fridericia correction of the QT measure (QTcF) interval of >480 ms at Screening (unless secondary to pacemaker or bundle branch block)
  19. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary
  20. Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk.

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Arm Description

Participants will receive escalating doses of loncastuximab tesirine (initial dose of 60 μg/kg and highest dose possibly tested of 150 µg/kg) in combination with R-CHOP (rituximab 375 mg/m^2, cyclophosphamide 750 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2, and prednisone 100 mg/day) according to a standard 3+3 dose escalation design. The dose escalation part will be completed once the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) has been identified.

Participants will receive the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as determined in Part 1.

Outcomes

Primary Outcome Measures

Number of Participants Who Experience Dose Limiting Toxicities (DLTs) in Part 1
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Frequency and severity of TEAEs and treatment-emergent serious adverse events (SAEs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction
Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Values
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Signs
Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status will be measured on a scale from grades 0-5, where a higher grade indicates a worse outcome.
Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiograms (ECGs)
Number of Participants Who Experience a Clinically Significant Change from Baseline in Left Ventricular Ejection Fraction (LVEF) Assessments

Secondary Outcome Measures

Overall Response Rate (ORR)
Duration of Response (DOR)
Progression Free Survival (PFS)
Overall Survival (OS)
Complete Response Rate
Average Concentration of Loncastuximab Tesirine
Maximum Concentration (Cmax) of Loncastuximab Tesirine
Time to Maximum Concentration (Tmax) of Loncastuximab Tesirine
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine
Area Under the Concentration-Time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine
Apparent Terminal Elimination Half-Life (Thalf) of Loncastuximab Tesirine
Clearance of Loncastuximab Tesirine
Steady-State Volume of Distribution (Vss) of Loncastuximab Tesirine
Accumulation Index of Loncastuximab Tesirine
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine

Full Information

First Posted
July 22, 2021
Last Updated
March 15, 2022
Sponsor
ADC Therapeutics S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04974996
Brief Title
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)
Acronym
LOTIS-8
Official Title
A Phase 1b, Open-Label, Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With R-CHOP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Decision to not proceed with study.
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
May 5, 2027 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, and identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combination therapy.
Detailed Description
This is a Phase 1b, open-label, multi-center study in participants with previously untreated DLBCL, with a dose escalation part followed by dose expansion part. Participants will be treated by loncastuximab tesirine in combination with R CHOP. The duration of the study participation for each participant is defined as the time from the date of signed written informed consent to the completion of the follow-up period, withdrawal of consent, lost to follow-up, or death, whichever occurs first. The study will include a Screening Period (of up to 28 days), a Treatment Period of 6 cycles (cycles of 3 weeks), and a Follow-up Period (approximately every 12 week visits) for up to approximately 3 years from end-of-treatment (EOT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma
Keywords
Diffuse Large B-Cell Lymphoma, Untreated Diffuse Large B-Cell Lymphoma, DLBCL, Loncastuximab Tesirine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive escalating doses of loncastuximab tesirine (initial dose of 60 μg/kg and highest dose possibly tested of 150 µg/kg) in combination with R-CHOP (rituximab 375 mg/m^2, cyclophosphamide 750 mg/m^2, doxorubicin 50 mg/m^2, vincristine 1.4 mg/m^2, and prednisone 100 mg/day) according to a standard 3+3 dose escalation design. The dose escalation part will be completed once the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) has been identified.
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as determined in Part 1.
Intervention Type
Drug
Intervention Name(s)
Loncastuximab tesirine
Other Intervention Name(s)
ADCT-402, ZYNLONTA
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Orally via tablet or capsule
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Number of Participants Who Experience Dose Limiting Toxicities (DLTs) in Part 1
Time Frame
Day 1 to Day 21 of Cycle 1, where a cycle is 21 days
Title
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Description
Frequency and severity of TEAEs and treatment-emergent serious adverse events (SAEs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time Frame
Day 1 up to End of Treatment (up to 30 days after last dose of study treatment in this study or start of a new anticancer therapy, whichever is earlier; approximately 20 weeks)
Title
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Delay
Time Frame
Day 1 up to approximately 18 weeks
Title
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Interruption
Time Frame
Day 1 up to approximately 18 weeks
Title
Number of Participants Who Experience an Adverse Event (AE) Leading to Dose Reduction
Time Frame
Day 1 up to approximately 18 weeks
Title
Number of Participants Who Experience a Clinically Significant Change from Baseline in Safety Laboratory Values
Time Frame
Baseline (Day 1) to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Signs
Time Frame
Baseline (Day 1) to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Number of Participants Who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Description
ECOG performance status will be measured on a scale from grades 0-5, where a higher grade indicates a worse outcome.
Time Frame
Baseline (Day 1) to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Number of Participants Who Experience a Clinically Significant Change from Baseline in 12-Lead Electrocardiograms (ECGs)
Time Frame
Baseline (Day 1) to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Number of Participants Who Experience a Clinically Significant Change from Baseline in Left Ventricular Ejection Fraction (LVEF) Assessments
Time Frame
Baseline (Screening) to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Time Frame
Up to approximately 3.5 years
Title
Duration of Response (DOR)
Time Frame
Up to approximately 3.5 years
Title
Progression Free Survival (PFS)
Time Frame
Up to approximately 3.5 years
Title
Overall Survival (OS)
Time Frame
Up to approximately 3.5 years
Title
Complete Response Rate
Time Frame
Up to approximately 3.5 years
Title
Average Concentration of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Maximum Concentration (Cmax) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Time to Maximum Concentration (Tmax) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Area Under the Concentration-Time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Apparent Terminal Elimination Half-Life (Thalf) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Clearance of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Steady-State Volume of Distribution (Vss) of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Accumulation Index of Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)
Title
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time Frame
Day 2 to End of Treatment (up to 30 days after last dose of study treatment; approximately 20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent must be obtained prior to any study procedures Male or female participant aged 18 years or older Pathologic diagnosis of diffuse large B-cell lymphoma (DLBCL), as defined by the 2016 World Health Organization classification (including participants with DLBCL transformed from indolent lymphoma), or high-grade B cell lymphoma Measurable disease as defined by the 2014 Lugano Classification Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue sample. (If tissue block is not available, slides from a FFPE block may be acceptable for eligibility upon consultation with the Sponsor) Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Adequate organ function as defined by screening laboratory values within the following parameters: Absolute neutrophil count ≥1.5 × 10^3/μL (off growth factors at least 72 hours) Platelet count ≥75 × 10^3/μL without transfusion in the past 7 days Hemoglobin ≥9 g/dL (4.96 mmol/L), transfusion allowed Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN) Total bilirubin ≤1.5 × ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN) Calculated creatinine clearance >30 mL/min by the Cockcroft and Gault equation Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility. Left ventricular ejection fraction (LVEF) of ≥50%, assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the last dose of study drug. Women of childbearing potential are defined as sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (i.e., who have not menstruated at all) for at least one year. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective forms of birth control include: hormonal contraceptives (oral, injectable, patch, intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the participant. Note: The double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide-only are not acceptable as highly effective methods of contraception. Exclusion Criteria: Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a cluster of differentiation 19 (CD19) antibody Previous therapy with loncastuximab tesirine, rituximab, anthracycline, or cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) Known history of hypersensitivity to any component of study treatment (loncastuximab tesirine and rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) Previous treatment for aggressive lymphoma (with exception of short corticosteroid course [up to 7 days] for symptom management) Contraindication to receive granulocyte colony stimulating factors Human immunodeficiency virus (HIV) seropositive with any of the following: Cluster of differentiation 4 (CD4) + T-cell (CD4+) counts <350 cells/μL Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of Screening HIV viral load ≥400 copies/mL Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load History of Stevens-Johnson syndrome or toxic epidermal necrolysis Lymphoma with active central nervous system involvement at the time of Screening, including leptomeningeal disease 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) Breastfeeding or pregnant Significant medical comorbidities, including but not limited to, uncontrolled hypertension (blood pressure [BP] ≥160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to Screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease. Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at the time of Screening Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1 [C1D1]; cycle is 21 days), except shorter if approved by the Sponsor Use of any other experimental medication within 14 days prior to start of study drug (C1D1; cycle is 21 days) Received live vaccine within 4 weeks of C1D1; cycle is 21 days Congenital long measure between Q wave and T wave in the electrocardiogram (QT) syndrome or a corrected Fridericia correction of the QT measure (QTcF) interval of >480 ms at Screening (unless secondary to pacemaker or bundle branch block) Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk.
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)

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