A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00193492
Phase
PHASE2
Status
Completed

Conditions

  • Lymphoma, Follicular

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.

Key Dates

Start date
Sep 30, 2005
Status verified
Dec 2014
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
    All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
  • Experimental: Rituximab/Bevacizumab
    All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.

Primary Outcome Measure

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]

Locations (22)

FacilityCityStateZIPSite coordinators
Northeast Arkansas ClinicJonesboroArkansas72401-
Florida Cancer SpecialistsFort MyersFlorida33901-
Integrated Community Oncology NetworkJacksonvilleFlorida32256-
Watson Clinic for Cancer ResearchLakelandFlorida33805-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Medical Oncology Associates of AugustaAugustaGeorgia30901-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Wellstar Cancer ResearchMariettaGeorgia30060-
Providence Medical GroupTerre HauteIndiana47802-
Graves-Gilbert ClinicBowling GreenKentucky42101-
Baptist Hospital EastLouisvilleKentucky40207-
Norton Cancer InstituteLouisvilleKentucky40207-
Hematology Oncology Clinic, LLPBaton RougeLouisiana70809-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
National Capital Clinical Research ConsortiumBethesdaMaryland20817-
Methodist Cancer CenterOmahaNebraska68114-
Hematology Oncology Associates of Northern NJMorristownNew Jersey07960-
Oncology Hematology CareCincinnatiOhio45242-
Berks Hematology Oncology AssociatesWest ReadingPennsylvania19611-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Jonesboro, AR

By research site
Northeast Arkansas Clinic· Jonesboro, ARFlorida Cancer Specialists· Fort Myers, FLIntegrated Community Oncology Network· Jacksonville, FLWatson Clinic for Cancer Research· Lakeland, FLFlorida Hospital Cancer Institute· Orlando, FLMedical Oncology Associates of Augusta· Augusta, GA

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