No. 197 Ruijin 2nd Road, Huangpu District, Shanghai
Shanghai, Shanghai Municipality, China
Location status: Recruiting
NCT Number: NCT06701357
This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, China
Location status: Recruiting
Participants who met the inclusion/exclusion criteria signed informed consent and received 1 course of CR-CHOP, followed by stratification of the remaining 5 cycles based on genetic subtypes. C1 plus PD1 inhibitor; C2 and C3 were treated with orelabrutinib. TP53mut plus decitabine. During chemotherapy, routine evaluation was performed after each course of treatment, and an objective comprehensive evaluation of efficacy was performed after 3 courses of treatment. Efficacy evaluation Patients with CR or PR should continue the original treatment, and patients with SD or PD should be recommended second-line salvage treatment. For the first summary evaluation after completion of all treatments, CR patients are placed on chidamide maintenance therapy (2 years recommended unless intolerable toxicity or disease progression occurs).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rituximab 375 mg/m2 D1; Cyclophosphamide 750mg/m2 D2; Doxorubicin 50mg/m2 D2; Vincristine 1.4 mg/m2 D2; Prednisone 60 mg/m2 D2-6; Chidamide 20mg/d D1,4,8,11; PD1 200mg D1
Rituximab 375 mg/m2 D1; Cyclophosphamide 750mg/m2 D2; Doxorubicin 50mg/m2 D2; Vincristine 1.4 mg/m2 D2; Prednisone 60 mg/m2 D2-6; Chidamide 20mg/d D1,4,8,11; Orelabrutinib 150mg/qd D1-21
Rituximab 375 mg/m2 D1; Cyclophosphamide 750mg/m2 D2; Doxorubicin 50mg/m2 D2; Vincristine 1.4 mg/m2 D2; Prednisone 60 mg/m2 D2-6; Chidamide 20mg/d D1,4,8,11; Decitabine 10mg/m2 D-5 - -1
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator
Time frame: 2-year
PFS, defined as the time from treatment to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator
Time frame: 2-year
OS defined as the time from treatment to death from any cause
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
A Prospective, Open-label Phase II Study of Chidamide Plus R-CHOP + X in Previously Untreated Diffuse Large B-cell Lymphoma with Double Expression of MYC and BCL2.
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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