NCT00634179

A Phase I/II Trial of VR-CHOP in Lymphoma Patients

A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).

Detailed description

This study will assess whether adding bortezomib (Velcade) to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment. Patients who are eligible to take part in the study will receive VR-CHOP at the doses of Velcade and vincristine established in phase 1. Patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects. All patients will go on to receive maintenance therapy after completion of their initial treatment as designed by the protocol.

Conditions

• Lymphoma, B-Cell
• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib 1.6 mg/m² given on days 1 and 8
BIOLOGICAL	Rituximab	Rituximab 375 mg/m²
DRUG	Doxorubicin	Doxorubicin 50 mg/m²
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m²
DRUG	Vincristine	Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
DRUG	Prednisone	Prednisone 100 mg/day given orally on days 1-5

Timeline

• Start date: 2008-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2008-03-12
• Last updated: 2016-10-27
• Results posted: 2016-03-15

Locations

1 site across 1 country: United States