Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02957019
Status:
TERMINATED
Last Update Posted:
2023-10-10
First Post:
2016-10-27
Brief Title:
A Phase III 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
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
A Phase III 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
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow progression due to difficulties in finding eligible patients Competitive clinical trials with innovative agents and new approved products leaddefinitive stop
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase III 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 mgm2
Phase II - Activity Evaluation Open-label multi-center prospective study during which 14 enrolled patients will receive a fixed dose of Rituximab 375 mgm2 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
Phase II - Activity Evaluation Open-label multi-center prospective study during which 14 enrolled patients will receive a fixed dose of Rituximab 375 mgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None