Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680038
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-11
First Post:
2022-12-15
Brief Title:
Penpulimab in Maintenance Therapy in Lymphoma
Sponsor:
WEI XU
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Real-world Study of Efficacy and Safety of Penpulimab in Maintenance Therapy in Patients With Post-transplant or Transplant-intolerant Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Panpulimab is a modified PD1 inhibitor which innovated the use of IgG1 subtype On the basis of ensuring the stability of the antibody it eliminated ADCC ADCP CDC and other effects that were not conducive to the efficacy of T cells and reduced the effect of ADCR by modifying the Fc segment There have been no studies on the safety and efficacy of Panpulimab in maintenance therapy after transplantation or in patients with transplant-intolerant lymphoma The maintenance treatment of Panpulimab in our center has been preliminarily explored in clinic and the results show good efficacy and safety Therefore based on the mechanism of PD1 monoclonal antibody maintenance therapy in lymphoma and the results of related clinical studies this study proposed a regimen of peamprilizumab maintenance therapy for post-transplant or transplant intolerant lymphoma patients in real world studies with the main purpose of observing the efficacy and safety of this regimen in lymphoma patients
Detailed Description:
After the completion of first-line induction and consolidation therapy the lymphoma patients who received transplantation or were intolerant to transplantation were treated with Panpulimab monotherapy 200 mg once every three weeks and were evaluated after six months of maintenance therapy The patients who were evaluated as CR were excluded from the group and the patients who did not reach CR were continued to take medication until CR Review every 3 months from the first year of maintenance treatment and every 6 months from the second year to the fifth year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None