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

A Randomized, Open-Label, Multicenter, Phase 2 Study 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000929

Enrollment

164

Registered

2010-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diffused Large B Cell Lymphoma

Interventions

Intervention1: Velcade, Rituximab, Cyclophosphamide, Doxorubicin, prednisone (VR-CAP): 6 cycles of 21 day each Intervention2: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, prednisone (R-CHOP)

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary objective is to determine the complete response (CR) rate following treatment with VR-CAP (VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone) or standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in subjects with newly diagnosed non-germinal center B-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).Timepoint: End of the treatment	—

Measure

Time frame

The primary objective is to determine the complete response (CR) rate following treatment with VR-CAP (VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone) or standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in subjects with newly diagnosed non-germinal center B-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).Timepoint: End of the treatment

—

Secondary

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

Countries

India

Contacts

Public ContactDr Jitendra R Dixit

Global Clinical Operations

jdixit@its.jnj.com912266646464

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026