A Phase I/II Trial of VR-CHOP in Lymphoma Patients
NCT00634179 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2016-10-27
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).
Conditions
- Lymphoma, B-Cell
- Follicular Lymphoma
Interventions
- DRUG
-
Bortezomib 1.6 mg/m² given on days 1 and 8
- BIOLOGICAL
-
Rituximab 375 mg/m²
- DRUG
-
Doxorubicin
Doxorubicin 50 mg/m²
- DRUG
-
Cyclophosphamide 750 mg/m²
- DRUG
-
Vincristine
Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
- DRUG
-
Prednisone 100 mg/day given orally on days 1-5
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY -
Emory University
lead OTHER
Principal Investigators
-
Christopher Flowers, MD · Emory University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
Countries
- United States
Study Locations
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