NCT05222438

Trial of Loncastuximab Tesirine in High Risk Diffuse Large B-cell Lymphoma Post Transplant

Phase II Trial Evaluating Safety and Efficacy of Loncastuximab Tesirine as a Maintenance Therapy Following Autologous Stem Cell Transplantation in High Risk Diffuse Large B-cell Lymphoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study of loncastuximab tesirine administered intravenously (IV) for maintenance therapy following autologous stem cell transplant in patients with relapsed diffuse large B cell lymphoma

Detailed description

This is a Phase II, multicenter, open label study of loncastuximab tesirine for maintenance therapy following autologous stem cell transplant (autoSCT) in patients with relapsed diffuse large B cell lymphoma (DLBCL). Patients with relapsed DLBCL confirmed through core biopsy and meeting eligibility criteria will be enrolled in the study. Patients can be enrolled up to 4 weeks prior to autoSCT. Patients will start loncastuximab tesirine between day 30 and 60 after autoSCT as determined by the treating physician. Since majority of the relapses occur early after autoSCT, offering maintenance therapy for a finite duration might be of therapeutic benefit without posing excessive toxicity. Loncastuximab tesirine will be administered intravenously (IV) at every 3 weeks (Q3W) for a total of 6 months (8 cycles).

Conditions

• Relapsed Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	loncastuximab tesirine	loncastuximab tesirine for maintenance therapy between day 30 and 60 following autoSCT and will receive a total of 6 months of therapy (8 cycles).

Timeline

• Start date: 2022-04-08
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-02-03
• Last updated: 2023-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study