Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630091
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
A Phase II Single-center Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients GOLDEN Study and Correlative Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Single-center Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients GOLDEN Study and Correlative Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL
Detailed Description:
Primary Objectives
To assess the 2-year progression-free survival rate of golidocitinib as primary efficacy endpoint in participants with newly diagnosed PTCL
Secondary Objectives
To assess the anti-tumor efficacy of golidocitinib using PETCT-based objective response rate ORR complete response rate CRR duration of response DoR progression-free survival PFS and time to response TTR assessed according to the 2014 Lugano classification as secondary efficacy endpoint in patients with newly diagnosed PTCL
To assess the safety and tolerability of golidocitinib in participants with newly diagnosed PTCL according to the adverse events graded by CTCAE version 50
Exploratory Objectives
To identify participant selection biomarkers derived from tumor and plasma at baseline and correlate these biomarkers with tumor response to golidocitinib
Evaluate potential mechanisms of resistance to golidocitinib in plasma and tumor biopsies of PTCL participants at baseline and upon progression
To assess the 2-year progression-free survival rate of golidocitinib as primary efficacy endpoint in participants with newly diagnosed PTCL
Secondary Objectives
To assess the anti-tumor efficacy of golidocitinib using PETCT-based objective response rate ORR complete response rate CRR duration of response DoR progression-free survival PFS and time to response TTR assessed according to the 2014 Lugano classification as secondary efficacy endpoint in patients with newly diagnosed PTCL
To assess the safety and tolerability of golidocitinib in participants with newly diagnosed PTCL according to the adverse events graded by CTCAE version 50
Exploratory Objectives
To identify participant selection biomarkers derived from tumor and plasma at baseline and correlate these biomarkers with tumor response to golidocitinib
Evaluate potential mechanisms of resistance to golidocitinib in plasma and tumor biopsies of PTCL participants at baseline and upon progression
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