Interim PET/CT Guided Cycle Numbers of R-CHOP in DLBCL
Phase 2
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Drug: R-CHOP
- Registration Number
- NCT01804127
- Lead Sponsor
- Fudan University
- Brief Summary
The aim of this study is to optimize the number of cycles of R-CHOP in patients with diffuse large B-cell lymphoma based on the interim results of PET/CT.
- Detailed Description
R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL). However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles based on the interim results of PET/CT in order to avoid treatment exposure.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 196
Inclusion Criteria
- Previously untreated diffuse large B-cell lymphoma
- Age range 18-80 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 R-CHOP R-CHOP rituximab 375mg/m2 day 0, cyclophosphamide 750mg/m2 IV day 1, doxorubicin 50mg/m2 IV day 1, vincristine 1.4mg/m2 IV day1 (maximum: 2mg), 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 Objective response rate 6 months 3-year overall survival 3 years
Trial Locations
- Locations (1)
Fudan University Cancer Hospital
🇨🇳Shanghai, Shanghai, China