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A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL
Sponsor: Xia Yi
Summary
Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) plus CHOP versus standard-dose rituximab plus CHOP in previously untreated (TN) stage III-IV male DLBCL patients
Official title: A Phase III Randomized Controlled Study Comparing High-dose Rituximab (500 mg/m²) Combined With CHOP Regimen Versus Standard-dose Rituximab (375 mg/m²) Combined With CHOP Regimen in Male Patients With Newly Diagnosed Advanced Diffuse Large B-cell Lymphoma
Key Details
Gender
MALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
428
Start Date
2024-08-23
Completion Date
2027-07-12
Last Updated
2024-08-27
Healthy Volunteers
No
Conditions
Interventions
Rituximab
Patients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2 for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).