The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
Progression-free Survival (PFS)
Time frame: Up to 4 years
Overall Survival (OS)
Time frame: Up to 4 years
Overall Response Rate (ORR)
Time frame: Up to 4 years
Complete Response Rate (CRR)
Time frame: Up to 4 years
Duration of Response (DOR)
Time frame: Up to 4 years
Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: Day 1 up to a maximum of Week 39
Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
Time frame: Up to 4 years
Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
Time frame: Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
Time frame: Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations
Time frame: Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
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Intravenous Infusion
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Redlands Community Hospital
Redlands, California, United States
The Oncology Institute of Hope and Innovation
Whittier, California, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
UnityPoint Health - Iowa Oncology Research Association (IORA)
Des Moines, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Comprehensive Cancer Centers of Nevada - Henderson
Las Vegas, Nevada, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Virginia Cancer Specialists
Gainesville, Virginia, United States
...and 134 more locations
Time frame: Day 1 up to a maximum of Week 25
Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results
Time frame: Day 1 up to a maximum of Week 25
Average Concentration of Loncastuximab Tesirine at the End of Infusion
Time frame: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Average Concentration of Loncastuximab Tesirine Before Infusion
Time frame: Day 1 of Cycles 1 through 6 (each cycle is 3 weeks)
Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
Time frame: Day 1 up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Core 30 (EORTC QLQ-C30)
Time frame: Baseline up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by the Lymphoma Subscale of Functional Assessment of Cancer Therapy- Lymphoma (LymS of FACT-Lym)
Time frame: Baseline up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by GP5 Item of the Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
Time frame: Baseline up to a maximum of Week 25
Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: Baseline to up to 4 years