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NOT YET RECRUITING
NCT06573645
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).