Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550336
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Clinical Study Assessing the Efficacy of Chidamide for CD30-positive Peripheral T-cell Lymphoma PTCL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-center Open-label Clinical Trial to Evaluate the Efficacy and Safety of Chidamide Monotherapy for Maintenance Therapy in CD30 Peripheral T-cell Lymphoma PTCL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
ObjectiveThis study aims to assess the efficacy and safety of Chidamide as a monotherapy maintenance treatment for patients with newly diagnosed peripheral T-cell lymphoma PTCL who have achieved remission or stable disease after initial brentuximab vedotin BV plus cyclophosphamide doxorubicin and prednisone CHPtreatment excluding ALK anaplastic large-cell lymphoma ALCL
Design The study is a prospective single-center open-label clinical trial
TreatmentEligible patients will receive Chidamide tablets at a dosage of 20 mg 4 tablets twice weekly Treatment cycles are 4 weeks long and will continue until disease progression unacceptable toxicity patient withdrawal investigator decision to discontinue loss to follow-up death or study termination
EndpointsThe primary endpoint is the 2-year progression-free survival PFS Secondary endpoints include the overall response rate ORR overall survival OS and safety indicators
RationaleThe study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients
Design The study is a prospective single-center open-label clinical trial
TreatmentEligible patients will receive Chidamide tablets at a dosage of 20 mg 4 tablets twice weekly Treatment cycles are 4 weeks long and will continue until disease progression unacceptable toxicity patient withdrawal investigator decision to discontinue loss to follow-up death or study termination
EndpointsThe primary endpoint is the 2-year progression-free survival PFS Secondary endpoints include the overall response rate ORR overall survival OS and safety indicators
RationaleThe study seeks to provide a basis for the dosing regimen of Chidamide and contribute to the development of effective maintenance treatment strategies for PTCL patients
Detailed Description:
None
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