Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

Part of paid clinical trials in San Diego, California.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00553501
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • epratuzumab — BIOLOGICAL
    Days 1, 8, 15, 22 and weeks 12, 20, 28, \& 36: 360mg/sq m IV
  • rituximab — BIOLOGICAL
    Day 3, 8, 15, 22 and weeks 12, 20, 28, \& 36: 375mg/sq m IV

Study Details

RATIONALE: Monoclonal antibodies, such as epratuzumab and 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 epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma. PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

Key Dates

Start date
Mar 31, 2008
Status verified
Jul 2016
Primary completion
Jul 31, 2010
Completion
Jul 31, 2014

Study Design

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

Arms

  • Experimental: Epratuzumab Plus Rituximab
    Induction Therapy (Month 1): Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22 Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36

Primary Outcome Measure

Number of Participants With Overall Response [ Time Frame: 12 months ]

Locations (43)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Medical Office -Vandever Medical OfficeSan DiegoCalifornia92120-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
Middlesex Hospital Cancer CenterMiddletownConnecticut06457-
Tunnell Cancer Center at Beebe Medical CenterLewesDelaware19958-
CCOP - Christiana Care Health ServicesNewarkDelaware19713-
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Walter Reed Army Medical CenterWashington D.C.District of Columbia20307-5001-
University of Chicago Cancer Research CenterChicagoIllinois60637-1470-
University of Illinois Cancer CenterChicagoIllinois60612-7243-
Elkhart General HospitalElkhartIndiana46515-
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46845-
Howard Community HospitalKokomoIndiana46904-
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa PorteIndiana46350-
CCOP - Northern Indiana CR ConsortiumSouth BendIndiana46601-
Memorial Hospital of South BendSouth BendIndiana46601-
Saint Joseph Regional Medical CenterSouth BendIndiana46617-
South Bend ClinicSouth BendIndiana46617-
Hematology Oncology Associates of the Quad CitiesBettendorfIowa52722-
Union Hospital Cancer Program at Union HospitalElkton MDMaryland21921-
Dana-Farber/Brigham and Women's Cancer CenterBostonMassachusetts02115-
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBostonMassachusetts02115-
Lakeland Regional Cancer Care Center - St. JosephSaint JosephMichigan49085-
Oncology Care Associates, PLLCSaint JosephMichigan49085-
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbiaMissouri65203-
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt LouisMissouri63110-
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcordNew Hampshire03301-
New Hampshire Oncology - Hematology, PA - HooksettHooksettNew Hampshire03106-
Lakes Region General HospitalLaconiaNew Hampshire03246-
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-0002-
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees TownshipNew Jersey08043-
CCOP - Hematology-Oncology Associates of Central New YorkEast SyracuseNew York13057-
New York Weill Cornell Cancer Center at Cornell UniversityNew YorkNew York10021-
Wayne Memorial Hospital, IncorporatedGoldsboroNorth Carolina27534-
Kinston Medical SpecialistsKinstonNorth Carolina28501-
Iredell Memorial HospitalStatesvilleNorth Carolina28677-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbusOhio43210-1240-
Mountainview MedicalBerlin CornersVermont05602-
Fletcher Allen Health Care - University Health Center CampusBurlingtonVermont05401-
Danville Regional Medical CenterDanvilleVirginia24541-
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsvilleVirginia24115-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-0037-
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntingtonWest Virginia25702-

Find similar trials in San Diego, CA

By research site
Kaiser Permanente Medical Office -Vandever Medical Office· San Diego, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAMiddlesex Hospital Cancer Center· Middletown, CTTunnell Cancer Center at Beebe Medical Center· Lewes, DECCOP - Christiana Care Health Services· Newark, DELombardi Comprehensive Cancer Center at Georgetown University Medical Center· Washington D.C., DC

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