Chidamide Plus R-CHOP in Elderly DLBCL
Phase 2
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Registration Number
- NCT02753647
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
This is a prospective, single-arm, open-label phase II study of Chidamide in combination with R-CHOP in the treatment of de novo, elderly, high-risk diffuse large B cell lymphoma patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
- Age 61-75 years
- ECOG 0,1,2
- Life expectancy>6 months
- Informed consented
- IPI>1
Exclusion Criteria
- Chemotherapy before
- Stem cell transplantation before
- History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary CNS lymphoma
- LVEF≤50%
- Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Not able to comply to the protocol for mental or other unknown reasons
- Pregnant or lactation
- HIV infection
- If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chidamide plus R-CHOP Rituximab Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles Chidamide plus R-CHOP Cyclophosphamide Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles Chidamide plus R-CHOP Doxorubicin Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles Chidamide plus R-CHOP Prednisone Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles Chidamide plus R-CHOP Vincristine Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles Chidamide plus R-CHOP Chidamide Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Doxorubicin 50mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Chidamide 20mg/d PO d1, 4, 8, 11 Frequency every 21 days for 6 cycles
- Primary Outcome Measures
Name Time Method Complete response rate 21 days after 6 cycles of treatment (each cycle is 21 days)
- Secondary Outcome Measures
Name Time Method Progression free survival rate 2 year Overall survival rate 2 year Overall response rate 21 days after 6 cycles of treatment (each cycle is 21 days) Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Each cycle of treatment and then every 3 months for 2 years
Trial Locations
- Locations (1)
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China