Intensified 1st Cycle Rituximab Plus 8th Cycles of R-CHOP Chemotherapy in Patients With Advanced or Bulky CD20+ Diffuse Large B-cell Lymphoma (DLBCL)

Phase 2

Completed

• Conditions: Diffuse Large B-cell Lymphoma (DLBCL)

• Registration Number: NCT01054781
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-22
• Primary Completion: 2010-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-26
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the complete response (CR) rate after Intensified 1st cycle Rituximab plus 3rd cycles of R-CHOP in DLBCL and	12 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the overall response rate of R+R-CHOP	12 months
To evaluate the duration of overall response	12 months
To evaluate the safety and tolerability of the R+R-CHOP combination treatment.	12 months
To evaluate the progression free survival.	12 months
To estimate the overall survival.	12 months
To explore prognostic or predictive biomarkers	12 months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of