NCT05144009

A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)

A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: ADC Therapeutics S.A. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.

Detailed description

The primary objectives of this trial are shown below: Cohort A: To assess the efficacy of a response-adapted treatment of Lonca-R in unfit participants with previously untreated DLBCL, high-grade B cell lymphoma (HGBCL), or Grade 3b follicular lymphoma (FL). Cohort B: To assess the tolerability and efficacy of a response-adapted treatment of Lonca-R in frail participants with previously untreated DLBCL, or HGBCL, or Grade 3b FL who are ineligible for standard R-mini-CHOP. The simplified geriatric assessment (sGA) developed by the Fondazione Italiana Linfomi (FIL) identifies three distinct categories (fit, unfit, and frail) based on age, activities of daily living (ADL), instrumental activities of daily living (IADL) and the Cumulative Illness Rating Scale for Geriatrics (CIRS-G). Participants will be assigned to Cohort A (unfit) or B (frail) using the sGA.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Loncastuximab Tesirine	Intravenous (IV) Infusion
DRUG	Rituximab	Cycle 1 - Intravenous (IV) Infusion. Cycle 2+ - Intravenous (IV) Infusion or Subcutaneous (SC) Administration.

Timeline

• Start date: 2022-06-21
• Primary completion: 2024-01-22
• Completion: 2024-01-22
• First posted: 2021-12-03
• Last updated: 2025-01-30
• Results posted: 2025-01-30

Locations

41 sites across 4 countries: United States, Italy, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study