Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01029730
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bendamustine — DRUG
    Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
  • Bortezomib — DRUG
    Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
  • Rituximab — DRUG
    Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1

Study Details

The goal of this multi-center Phase II study is to add bortezomib to the highly active regimen of bendamustine and rituximab. In this study, bortezomib will be administered on a weekly schedule (Days 1, 8, 15) and will be added to bendamustine/rituximab given in 4-week cycles. This combination uses the standard bendamustine dosing schedule, and is more convenient than the 5-week regimen of these 3 drugs currently being studied.

Key Dates

Start date
Mar 31, 2010
Status verified
Jul 2016
Primary completion
Oct 31, 2014
Completion
Jul 31, 2016

Study Design

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

Arms

  • Experimental: Bendamustine/Bortezomib/Rituximab
    Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.

Primary Outcome Measure

Complete Response Rate [ Time Frame: 18 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
NEA Baptist ClinicJonesboroArkansas72401-
Holy Cross HospitalFort LauderdaleFlorida33308-
Florida Cancer SpecialistsFort MyersFlorida33916-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Hematology Oncology of the North ShoreSkokieIllinois60076-
Providence Medical GroupTerre HauteIndiana47802-
Baptist Hospital EastLouisvilleKentucky40207-
Hematology Oncology Clinic, LLPBaton RougeLouisiana70806-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
National Capital Clinical Research ConsortiumBethesdaMaryland20817-
Grand Rapids Clinical Oncology ProgramGrand RapidsMichigan49503-
St. Louis Cancer CareChesterfieldMissouri63017-
Portsmouth Regional HospitalPortsmouthNew Hampshire03801-
Hematology-Oncology Associates of Northern NJMorristownNew Jersey07960-
Oncology Hematology CareCincinnatiOhio45242-
Cancer Centers of Southwest OklahomaLawtonOklahoma73505-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
Schiffler Cancer CenterWheelingWest Virginia26003-

Find similar trials in Jonesboro, AR

By research site
NEA Baptist Clinic· Jonesboro, ARHoly Cross Hospital· Fort Lauderdale, FLFlorida Cancer Specialists· Fort Myers, FLNortheast Georgia Medical Center· Gainesville, GAHematology Oncology of the North Shore· Skokie, ILProvidence Medical Group· Terre Haute, IN

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