Back to resultsStudy to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (LOTIS-2)
Primary Purpose
Diffuse Large B-Cell Lymphoma Refractory, Diffuse Large B-cell Lymphoma Recurrent
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Loncastuximab tesirine
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma Refractory focused on measuring Loncastuximab tesirine
Eligibility Criteria
Inclusion Criteria:
- Male or female patient aged 18 years or older.
- Pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification, to include: DLBCL not otherwise specified; primary mediastinal large B-cell lymphoma; and high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
- Relapsed or refractory disease following two or more multi-agent systemic treatment regimens
- Patients who have received previous CD19-directed therapy must have a biopsy that shows CD19 protein expression after completion of the CD19-directed therapy.
- Measurable disease as defined by the 2014 Lugano Classification
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or minimum 10 freshly cut unstained slides if block is not available
- ECOG performance status 0-2
- Adequate organ function
- Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential
- Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks 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 16 weeks after the patient receives his last dose of loncastuximab tesirine.
Exclusion Criteria:
- Previous treatment with loncastuximab tesirine
- Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody
- Pathologic diagnosis of Burkitt lymphoma
- 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
- Autologous stem cell transplant (ASCT) within 30 days prior to start of study drug (C1D1)
- Allogeneic stem cell transplant (AlloSCT) within 60 days prior to start of study drug (C1D1)
- Active graft-versus-host disease
- Post-transplant lymphoproliferative disorders
- Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
- Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV).
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Lymphoma with active CNS 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
- Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
- Use of any other experimental medication within 14 days prior to start of study drug (C1D1)
- Planned live vaccine administration after starting study drug (C1D1)
- Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening
- Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block)
- Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
Sites / Locations
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
- Compassionate Care Research Group, Inc., at Compassionate Care Medical Group, Inc.
- UC San Diego Moores Cancer Center
- University of California, San Francisco Medical Center
- The Oncology Institute of Hope and Innovation
- University of Miami Hospital and Clinics
- Miami Cancer Institute
- Winship Cancer Institute of Emory University
- Northside Hospital
- Northwest Georgia Oncology Centers, PC-Drug Shipment, Lab and Study Supplies Only
- Medical Oncology & Hematology Associates
- Ochsner Clinic Foundation
- Washington University School of Medicine
- University of Nebraska Medical Center/ Nebraska Medicine
- North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
- University Hospitals Cleveland Medical Center
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Hollings Cancer Center
- GHD Cancer Institute
- Baylor University Medical Center
- Baylor Scott & White Medical Center - Temple
- Virginia Cancer Specialists, PC
- Vista Oncology Inc. PS
- Froedtert Hospital & the Medical College of Wisconsin
- A.O. SS Antonio e Biagio e Cesare Arrigo
- Istituto di Ematologia Seragnoli
- U.O. Oncologia ed Ematologia
- Dipartimento di Oncomatlolgia - Unita Linfomi
- Divisione di Oncoematologia
- Anastasios Stathis
- University Hospitals of Leicester NHS Trust.
- University College London Hospital
- The Christie NHS Foundation Trust
- Oxford Cancer Centre, Churchill Hospital
- NHS Greater Glasgow and Clyde
- Abertawe Bro Morgannwg University Health Board - Singleton Hospital
- Nottingham University Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Loncastuximab tesirine
Arm Description
Participants will receive loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
ORR, as determined by central review according to the 2014 Lugano classification, defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Secondary Outcome Measures
Duration of Response (DOR)
DOR defined as the time from the first documentation of tumor response to disease progression or death.
Complete Response (CR) Rate
CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Relapse-free Survival (RFS)
RFS was defined as the time from the documentation of CR to disease progression or death.
Progression-free Survival (PFS)
PFS was defined as the time between start of treatment and the first documentation of recurrence, progression, or death.
Overall Survival (OS)
OS was defined as the time between the start of treatment and death from any cause.
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with treatment. A TEAE was an adverse event with an onset that began or worsened on or after the first dose date and until 30 days after the last dose date, or start of a new anticancer therapy/procedure, whichever came earlier. TEAE assessments also included those per the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥3 AEs and serious TEAEs.
AEs were graded using CTCAE version 4 and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. For events not listed in the CTCAE criteria, the same grading was used.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests
Clinical laboratory tests included hematology and chemistry. Clinically significant changes were determined by the Investigator.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital sign measurements included arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following:
0 = fully active, able to carry on all pre-disease performance without restriction
1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours
4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair
5 = dead
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
AI is the ratio of AUC0-last for each cycle divided by AUC0-last of the previous cycle.
Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
EQ-5D-5L is designed as an international, standardized, instrument for describing and evaluating quality of life (QoL). In the EQ-5D-5L VAS participants are asked to indicate their health state today on a VAS with the endpoints labeled 'the best health you can imagine' (score 100) and 'the worst health you can imagine' (score 0).
A higher score on the VAS indicates better health related QoL. A positive change from baseline indicates an improvement in health related QoL.
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS)
Composed of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the 15-item LymS. The FACT-G questionnaire contains 27 items covering 4 core health related quality of life (QoL) subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The LymS addresses issues including pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. Score range for the LymS was 0 - 60, where a higher score indicates less symptoms. The LymS score is reported. A positive change from baseline indicates an improvement in health related QoL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03589469
Brief Title
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Acronym
LOTIS-2
Official Title
A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-2)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
May 24, 2020 (Actual)
Study Completion Date
August 9, 2022 (Actual)
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 purpose of this Phase 2 study is to evaluate the clinical efficacy and safety of Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma.
Detailed Description
This is a Phase 2, multi-center, open-label, single-arm study of the efficacy and safety of loncastuximab tesirine used as monotherapy in patients with relapsed or refractory DLBCL. The study will enroll approximately 140 patients
Loncastuximab Tesirine is an antibody drug conjugate (ADC) composed of a humanized antibody directed against human cluster of differentiation 19 (CD19), stochastically conjugated through a cathepsin-cleavable linker to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Loncastuximab tesirine has been designed to target and kill CD19-expressing malignant B-cells.
A 2-stage design will be used in this clinical study, with an interim analysis for futility on the first 52 patients. If ≥10 patients respond (CR+PR), the study will proceed to complete full enrollment. Enrollment will continue during the interim analysis; however, further enrollment will be halted if futility is confirmed.
For each patient, the study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 weeks), and a Follow-up Period (approximately every 12 week visits for up to 3 years after treatment discontinuation).
Patients may continue treatment until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma Refractory, Diffuse Large B-cell Lymphoma Recurrent
Keywords
Loncastuximab tesirine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loncastuximab tesirine
Arm Type
Experimental
Arm Description
Participants will receive loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Loncastuximab tesirine
Other Intervention Name(s)
Zynlonta, ADCT-402
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR, as determined by central review according to the 2014 Lugano classification, defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR).
Time Frame
Up to 21.5 months
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
DOR defined as the time from the first documentation of tumor response to disease progression or death.
Time Frame
Up to 39 months
Title
Complete Response (CR) Rate
Description
CR rate defined as the percentage of treated participants with a best overall response (BOR) of CR.
Time Frame
Up to 39 months
Title
Relapse-free Survival (RFS)
Description
RFS was defined as the time from the documentation of CR to disease progression or death.
Time Frame
Up to 39 months
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time between start of treatment and the first documentation of recurrence, progression, or death.
Time Frame
Up to 40 months
Title
Overall Survival (OS)
Description
OS was defined as the time between the start of treatment and death from any cause.
Time Frame
Up to 43 months
Title
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with treatment. A TEAE was an adverse event with an onset that began or worsened on or after the first dose date and until 30 days after the last dose date, or start of a new anticancer therapy/procedure, whichever came earlier. TEAE assessments also included those per the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade ≥3 AEs and serious TEAEs.
AEs were graded using CTCAE version 4 and according to the following: Grade 1 = mild AE, Grade 2 = Moderate AE, Grade 3 = a severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. For events not listed in the CTCAE criteria, the same grading was used.
Time Frame
Up to 599 days
Title
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests
Description
Clinical laboratory tests included hematology and chemistry. Clinically significant changes were determined by the Investigator.
Time Frame
Baseline up to 599 days
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Description
Vital sign measurements included arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time Frame
Baseline up to 599 days
Title
Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
Description
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome. ECOG scores include the following:
0 = fully active, able to carry on all pre-disease performance without restriction
1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 = ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
3 = capable of only limited self-care; confined to bed or chair more than 50% of waking hours
4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair
5 = dead
Time Frame
Baseline and end of treatment (up to 599 days)
Title
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
Description
Clinically significant changes from baseline for 12-lead ECGs were measured as abnormal QT interval corrected by Fridericia formula (QTcF) and QT interval corrected by Bazett formula (QTcB) values.
Time Frame
Baseline up to 599 days
Title
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose and end of infusion
Title
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
Title
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
Title
Apparent Terminal Half-life (Thalf) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
Title
Apparent Clearance (CL) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
Title
Apparent Volume of Distribution at Steady State (Vss) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
Title
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
Description
AI is the ratio of AUC0-last for each cycle divided by AUC0-last of the previous cycle.
Time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
Title
Number of Participants With an Anti-drug Antibody (ADA) Response to Loncastuximab Tesirine
Time Frame
Up to 599 days
Title
Change From Baseline Score in the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
Description
EQ-5D-5L is designed as an international, standardized, instrument for describing and evaluating quality of life (QoL). In the EQ-5D-5L VAS participants are asked to indicate their health state today on a VAS with the endpoints labeled 'the best health you can imagine' (score 100) and 'the worst health you can imagine' (score 0).
A higher score on the VAS indicates better health related QoL. A positive change from baseline indicates an improvement in health related QoL.
Time Frame
Baseline, Day 1 of Cycles 2 to 26 (cycle duration of 3 weeks), and end of treatment (up to 599 days)
Title
Change From Baseline Score in the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) - Lymphoma Subscale (LymS)
Description
Composed of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the 15-item LymS. The FACT-G questionnaire contains 27 items covering 4 core health related quality of life (QoL) subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The LymS addresses issues including pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. Score range for the LymS was 0 - 60, where a higher score indicates less symptoms. The LymS score is reported. A positive change from baseline indicates an improvement in health related QoL.
Time Frame
Baseline, Day 1 of Cycles 2 to 25 (cycle duration of 3 weeks), and end of treatment (up to 599 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient aged 18 years or older.
Pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification, to include: DLBCL not otherwise specified; primary mediastinal large B-cell lymphoma; and high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
Relapsed or refractory disease following two or more multi-agent systemic treatment regimens
Patients who have received previous CD19-directed therapy must have a biopsy that shows CD19 protein expression after completion of the CD19-directed therapy.
Measurable disease as defined by the 2014 Lugano Classification
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or minimum 10 freshly cut unstained slides if block is not available
ECOG performance status 0-2
Adequate organ function
Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential
Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks 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 16 weeks after the patient receives his last dose of loncastuximab tesirine.
Exclusion Criteria:
Previous treatment with loncastuximab tesirine
Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody
Pathologic diagnosis of Burkitt lymphoma
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
Autologous stem cell transplant (ASCT) within 30 days prior to start of study drug (C1D1)
Allogeneic stem cell transplant (AlloSCT) within 60 days prior to start of study drug (C1D1)
Active graft-versus-host disease
Post-transplant lymphoproliferative disorders
Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV).
History of Stevens-Johnson syndrome or toxic epidermal necrolysis
Lymphoma with active CNS 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
Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
Use of any other experimental medication within 14 days prior to start of study drug (C1D1)
Planned live vaccine administration after starting study drug (C1D1)
Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening
Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block)
Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
Facility Information:
Facility Name
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Compassionate Care Research Group, Inc., at Compassionate Care Medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
The Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
University of Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PC-Drug Shipment, Lab and Study Supplies Only
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Medical Oncology & Hematology Associates
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center/ Nebraska Medicine
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GHD Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor Scott & White Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Vista Oncology Inc. PS
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
Froedtert Hospital & the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
A.O. SS Antonio e Biagio e Cesare Arrigo
City
Alessandria
State/Province
AL
ZIP/Postal Code
15121
Country
Italy
Facility Name
Istituto di Ematologia Seragnoli
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
U.O. Oncologia ed Ematologia
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Dipartimento di Oncomatlolgia - Unita Linfomi
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Divisione di Oncoematologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Anastasios Stathis
City
Bellinzona
State/Province
Canton Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
University Hospitals of Leicester NHS Trust.
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
University College London Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Oxford Cancer Centre, Churchill Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7 LE
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G120YN
Country
United Kingdom
Facility Name
Abertawe Bro Morgannwg University Health Board - Singleton Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1 PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35513980
Citation
Hamadani M, Chen L, Song Y, Xu MK, Liao L, Caimi PF, Carlo-Stella C. Matching-adjusted Indirect Comparison of the Efficacy of Loncastuximab Tesirine Versus Treatment in the Chemoimmunotherapy Era for Relapsed/Refractory Diffuse Large B-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e738-e744. doi: 10.1016/j.clml.2022.04.006. Epub 2022 Apr 8.
Results Reference
derived
PubMed Identifier
34893942
Citation
Hess B, Townsend W, Ai W, Stathis A, Solh M, Alderuccio JP, Ungar D, Liao S, Liao L, Khouri L, Zhang X, Boni J. Efficacy and Safety Exposure-Response Analysis of Loncastuximab Tesirine in Patients with B cell non-Hodgkin Lymphoma. AAPS J. 2021 Dec 10;24(1):11. doi: 10.1208/s12248-021-00660-3.
Results Reference
derived
PubMed Identifier
34690090
Citation
Spira A, Zhou X, Chen L, Gnanasakthy A, Wang L, Ungar D, Curiel R, Liao L, Radford J, Kahl B. Health-Related Quality of Life, Symptoms, and Tolerability of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2022 Mar;22(3):158-168. doi: 10.1016/j.clml.2021.09.001. Epub 2021 Sep 22.
Results Reference
derived
PubMed Identifier
33989558
Citation
Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. doi: 10.1016/S1470-2045(21)00139-X. Epub 2021 May 11.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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