Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-29 @ 7:34 AM
Study NCT ID:
NCT06779435
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL
Sponsor:
Ruijin Hospital
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-02
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:
This is a prospective, observational, multicenter, cohort study with 400 newly treated DLBCL patients. To evaluate the clinical efficacy and safety of tucidinostat in the real-world treatment of primary diffuse large B-cell lymphoma
Detailed Description:
The study was divided into 2 cohorts. Cohort 1: DLBCL patients diagnosed unfit/ Unfit. A person who is unfit/ unfit is defined as being 80 years or older, or younger than 80 years old but has comorbidities and cannot tolerate a standard dose of chemotherapy as determined by the investigator. Reference options for a combination regimen include C-R2, C-R-mini-CHOP, etc.
Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. Reference options for a combination regimen include CR-CHOP, C-Pola-R-CHP, etc.
Cohort 2: Patients diagnosed with DLBCL who cannot be classified as unfit/ Unfit. Reference options for a combination regimen include CR-CHOP, C-Pola-R-CHP, etc.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: