Diffuse Large B-cell Lymphoma
Conditions
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.
Interventions
DRUGRituximab
DRUGCyclophosphamide
DRUGDoxorubicin
DRUGVincristine
DRUGPrednisone
DRUGChidamide
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
61 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | 21 days after 6 cycles of treatment (each cycle is 21 days) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWeili Zhao, MD，PhD
Backup ContactPengpeng Xu, MD
Outcome results
None listed