A clinical trial to study the effects of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
Phase 2
Completed
- Conditions
- Health Condition 1: null- Diffused Large B Cell Lymphoma
- Registration Number
- CTRI/2009/091/000929
- Lead Sponsor
- Janssen Research Development LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 164
Inclusion Criteria
Histologically confirmed non-GCB DLBCL - done by central lab
-CD20 positive disease
-At least 1 measurable or assessable site of disease
Exclusion Criteria
-Prior anti-neoplastic (including unconjugated therapeutic antibodies) experimental or radiation therapy
-Peripheral neuropathy or neuropathic pain of grade 2 or worse
- Prior treatment with VELCADE
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to determine the complete response (CR) rate following treatment with VR-CAP<br>(VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone) or standard R-CHOP (rituximab,<br>cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in subjects with newly diagnosed<br>non-germinal center B-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).Timepoint: End of the treatment
- Secondary Outcome Measures
Name Time Method Determine duration of response (CR or PR)Timepoint: During the treatment;Determine overall response rate (ORR) (CR + partial response [PR])Timepoint: During the treatment