Diffuse Large B-cell Lymphoma
Conditions
Keywords
DLBCL, DA-EPOCH-R
Brief summary
The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
Detailed description
The prognosis of MYC positive diffuse large B-cell lymphoma (DLBCL) is very poor even treated with R-CHOP regimen. Recently, dose-adjusted EPOCH-R was shown to be effective in patients with DLBCL and relapsed/refractory Burkitt lymphoma. The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.
Interventions
DRUGDA-EPOCH-R
rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Previously untreated MYC positive diffuse large B-cell lymphoma * Age range 18-70 years old * Eastern Cooperative Oncology Group performance status 0-2 * Life expectancy of more than 3 months * Adequate organ function
Exclusion criteria
* Primary or secondary central nervous system involvement * Previous serious cardiac disease * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | 4 months |
| 3-year overall survival | 3 years |
| Toxicity | 6 months |
Countries
China
Outcome results
None listed