Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Location status: Recruiting
Location contact
Haiyan Yang, PhD
CONTACT
Xi Chen, MD
CONTACT
Xi Chen, MD
CONTACT
NCT Number: NCT06674096
This is a prospective, single-arm, multicenter clinical study to evaluate the efficacy and safety of chidamide, rituximab combined with lenalidomide sequential immunochemotherapy in the treatment of newly diagnosed elderly double-expressor diffuse large B-cell lymphoma.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 2
Hangzhou, Zhejiang, 310022, China
Location status: Recruiting
Haiyan Yang, PhD
CONTACT
Xi Chen, MD
CONTACT
Xi Chen, MD
CONTACT
It is divided into 4 stages: screening period, induction therapy period, immunochemotherapy period and maintenance therapy period. The screening period was 28 days before the first dose. Introduction treatment period: Enrolled subjects received RLC regimen every 21 days for a cycle of 2 cycles. Immunochemotherapy phase: CR-miniCHOP regimen was administered after the completion of the introduction therapy phase. Every 21 days for a cycle, treatment for 4 cycles. Patients who achieved CR with induction therapy entered the maintenance treatment period, receiving 20 mg of chidamide d1,4,8,11 recommended 8 cycles. Patients who did not achieve CR were discontinued from the study and treated at the discretion of their physician.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Introduction treatment: Rituximab, lenalidomide, chidamide for 2 cycles:
rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-14, chidamide 20mg, d1,4,8,11.
Immunochemtherapy phase: CR CHOP for 4 cycles: chidamide 20mg d1,4,8,11,rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/ m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.
maintenance treatment period: chidamide d1,4,8,11
Time frame: From date of first day of treatment until the date of first documented date of disease progression or death from any cause, assessed up to 24 months
Progression Free Survival
Time frame: 21days after the end of treatment
overall response rate
Time frame: 21days after the end of treatment
complete response rate
Time frame: : From date of first day of treatment until the date of first documented date of death from any cause, assessed up to 24 months
Overall Survival
Time frame: From date of first day of treatment until 30 day after last treatment
Adverse event and serious adverse event
Time frame: At screening period, after 2 cycles of ZR2 regimen(each cycle is 21 days), after 2 cycles of RCHOP regimen(each cycle is 21 days) and 21days after the end of treatment
Assess the patient's performance status according to the Barthel index. Patients will be classified into 5 scales with the score ranging from 0 to 100: 0-20 points=extremely severe functional impairment; 25-45 points=severe functional impairment; 50-70 points=moderate functional impairment; 75-95 points=mild functional impairment; 100 points=normal. Higher scores mean a better outcome.
Contact information is provided by the study sponsor or research team.
Zhejiang Cancer Hospital
Other
Rituximab,Lenalidomide and Chidamide Followed by CR-CHOP in Elderly Patients with Newly-diagnosed Double-expressor Lymphoma
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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