No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
Shanghai, Shanghai Municipality, China
Location status: Recruiting
NCT Number: NCT06779435
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Shanghai, Shanghai Municipality, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reference options for a combined regimen include C-R2, C-R-mini-CHOP, etc.
Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. .Single-drug maintenance is recommended to last 24 weeks
Reference options for a combined regimen include CR-CHOP, C-Pola-R-CHP, etc.
Subjects whose efficacy is assessed as CR after the end of induction therapy will enter consolidation therapy. Tucidinostat maintenance therapy or autologous hematopoietic stem cell transplantation may be an option. Tucidinostat maintenance therapy will be performed every 3 weeks. Single-drug maintenance is recommended to last 24 weeks
Time frame: 2-year
The length of time from the start of treatment to the onset of disease progression, recurrence after CR, death from any cause, or the start of new therapy for residual lesions (including conversion therapy for lesions during the trial) after the end of combination therapy, whichever occurs first.
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
The number of subjects who achieved complete response (CR) at the end of combination therapy as a percentage of the total number of participants in the analysis.
Time frame: 2-year
The length of time from the start of treatment to the onset of disease progression or recurrence or death from any cause, whichever occurs first
Time frame: 2-year
From the start of treatment to the time of death from any cause.
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of Diffuse Large B-cell Lymphoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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