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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT00634179
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Feb 29, 2008
Status verified
Sep 2016
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (VR-CHOP regimen)
    INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression. MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I) [ Time Frame: Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Emory University Winship Cancer Institute· Atlanta, GA

Related Studies