Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma

Sponsor
NCIC Clinical Trials Group
Study ID
NCT00428142
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    375mg/m2 day 1
  • bortezomib — DRUG
    1.3mg/m2 days 1 \& 8
  • cyclophosphamide — DRUG
    750mg/m2 day 1
  • prednisone — DRUG
    40mg/m2 days 1-5
  • vincristine sulfate — DRUG
    1.4mg/m2 day 1 (dose capped at 2mg)

Study Details

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with combination chemotherapy and rituximab works when given as first-line therapy in treating patients with stage III or stage IV follicular non-Hodgkin's lymphoma.

Key Dates

Start date
May 1, 2007
Status verified
Nov 2012
Primary completion
Apr 30, 2011
Completion
Jan 6, 2012

Study Design

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

Arms

  • Experimental: Bortezomib + BCVP-R
    BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1

Primary Outcome Measure

Complete response rate [ Time Frame: 5 years ]

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