Dose-adjusted EPOCH-R in MYC Positive DLBCL
Phase 2
Terminated
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Drug: DA-EPOCH-R
- Registration Number
- NCT01914718
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DA-EPOCH-R DA-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
- Primary Outcome Measures
Name Time Method 3-year progression-free survival 3 years
- Secondary Outcome Measures
Name Time Method 3-year overall survival 3 years Objective response rate 4 months Toxicity 6 months
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China