NCT02957019

A Phase I/II Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Rituximab in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase I/II, open-label, multicenter, prospective study.

Detailed description

Phase I - Dose definition: A prospective, open-label, multi-center Phase I dose escalation study in which cohorts of 3-6 patients will receive escalating doses of L19-IL2 in combination with a fixed dose of Rituximab (375 mg/m2). Phase II - Activity Evaluation: Open-label, multi-center, prospective study during which 14 enrolled patients will receive a fixed dose of Rituximab (375 mg/m2) in combination with L19-IL2 at the RD defined during the Phase I part of the study. The study is designed to establish whether L19-IL2, administered in combination with Rituximab is well tolerated and can achieve objective responses and clinical benefit to patients with relapsed or refractory DLBCL.

Conditions

• Diffuse Large B-cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	L19-IL2 - Ph I	Patients will receive increasing doses of L19-IL2 (0.32, 0.43, 0.57 and 0.76 Mio IU/kg of IL-2 equivalents per administration) during Phase I study
DRUG	L19-IL2 at RD - Ph II	Patients will receive L19-IL2 at the RD defined during the Phase I part of the study
DRUG	Rituximab	Patients will receive a fixed dose of Rituximab (375 mg/m2) per administration during Phase I and Phase II of the study

Timeline

• Start date: 2013-07-31
• Primary completion: 2023-09-01
• Completion: 2023-09-29
• First posted: 2016-11-07
• Last updated: 2023-10-10

Locations

1 site across 1 country: Germany