Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Official Title

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

Summary:

The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Overall Response Rate (ORR)
  • Complete Response Rate (CRR)
  • Duration of Response (DOR)
  • Number of Participants Who Experience At Least One Treatment-Emergent Adverse Event (TEAE)
  • Number of Participants Who Experience At Least One Serious Adverse Event (SAE)
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Clinical Laboratory Results
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Vital Sign Measurements
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Physical Examinations
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Number of Participants Who Experience a Clinically Significant Change From Baseline in Electrocardiogram (ECG) Results
  • Average Concentration of Loncastuximab Tesirine at the End of Infusion
  • Average Concentration of Loncastuximab Tesirine Before Infusion
  • Number of Participants With Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine
  • 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)
  • 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)
  • 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)
  • Part 2: Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured by EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society