Diffuse Large B-cell Lymphoma
Conditions
Keywords
DLBCL, R-CHOP, PET/CT
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.
Interventions
DRUGR-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
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate | 6 months |
| 3-year overall survival | 3 years |
Countries
China
Contacts
Primary ContactYe Guo, MD
Outcome results
None listed