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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
NameTimeMethod
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
NameTimeMethod
Determine duration of response (CR or PR)Timepoint: During the treatment;Determine overall response rate (ORR) (CR + partial response [PR])Timepoint: During the treatment
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