Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492629
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Toripalimab Combined With Chidamide for the Treatment of RelapsedRefractory Peripheral T-Cell Lymphoma
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Phase II Clinical Study of Toripalimab Combined With Chidamide for the Treatment of RelapsedRefractory Peripheral T-Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
To evaluate the efficacy of Toripalimab combined with Chidamide in the treatment of relapsedrefractory peripheral T-cell lymphoma
Detailed Description:
The study is an open-label single-arm single-center Phase II clinical trial The trial design adopts the Simon optimal two-stage design The number of effective cases in the first stage is 15 if fewer than 5 effective cases are observed the trial will be terminated otherwise the trial will continue The total sample size for the trial is at least 43 cases All subjects receive treatment with the Toripalimab and Chidamide regimen until the subject has been treated for 2 years disease progression occurs intolerable toxic reactions occur or treatment is terminated for other reasons whichever comes first After the end of treatment subjects are required to complete the end-of-treatment visit within 7 days Safety follow-up after the last dose is required at 30 days 7 days and 90 days 7 days after the last dose with adverse event AE collection up to 90 days after the last dose After the end of dosing subjects enter the follow-up period with a telephone follow-up every 12 weeks 7 days to collect survival information and subsequent anti-tumor treatments until death or loss to follow-up If a subject discontinues treatment for reasons other than PD progressive disease efficacy evaluation should continue at the same frequency as during the dosing period until the subject experiences PD starts a new anti-tumor treatment dies or is lost to follow-up
Treatment should be continued as long as clinical benefit is observed until the patient is no longer tolerating it for a maximum of 2 years of treatment Atypical responses may be observed for example a temporary increase in tumor size or the appearance of new small lesions within the first few months followed by a reduction in tumor size If the patients clinical symptoms are stable or continue to improve even with preliminary evidence of disease progression based on the overall judgment of clinical benefit it may be considered to continue treatment with this regimen until disease progression is confirmed
Treatment should be continued as long as clinical benefit is observed until the patient is no longer tolerating it for a maximum of 2 years of treatment Atypical responses may be observed for example a temporary increase in tumor size or the appearance of new small lesions within the first few months followed by a reduction in tumor size If the patients clinical symptoms are stable or continue to improve even with preliminary evidence of disease progression based on the overall judgment of clinical benefit it may be considered to continue treatment with this regimen until disease progression is confirmed
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