The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
Who is this study for? Patients with naive, low-risk, non-mass diffuse large B-cell lymphoma
What treatments are being studied? R-CHOP+Rituximab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 75
Healthy Volunteers: f
View:
• Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2)
• Treatment naïve
• IPI=0,1
• Age ≥ 14 or ≤75 years
• non-mass (The length of the lesion\<7.5cm)
• ECOG=0,1
• Life expectancy\>6 months
• Informed consented
Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao
zwl_trial@163.com
+862164370045
Backup
Pengpeng Xu
pengpeng_xu@126.com
+862164370045
Time Frame
Start Date: 2021-09-17
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 640
Treatments
Experimental: 4RCHOP+4R
Four Courses of R-CHOP Plus Four Courses of Rituximab
Experimental: 6RCHOP+2R
Six Courses of R-CHOP Plus Two Courses of Rituximab
Related Therapeutic Areas
Sponsors
Leads: Ruijin Hospital