A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Seagen Inc.
Study ID
NCT00529503
Phase
PHASE2
Status
Terminated

Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SGN-40 — DRUG
    2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
  • placebo — DRUG
    Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
  • rituximab — DRUG
    375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
  • etoposide — DRUG
    100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
  • carboplatin — DRUG
    AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
  • ifosfamide — DRUG
    5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Study Details

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

Key Dates

Start date
Sep 30, 2007
Status verified
Feb 2015
Primary completion
Dec 31, 2009
Completion
May 31, 2011

Study Design

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

Arms

  • Experimental: 1
    SGN-40, rituximab, etoposide, carboplatin, ifosfamide
  • Placebo Comparator: 2
    placebo, rituximab, etoposide, carboplatin, ifosfamide

Primary Outcome Measure

Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. [ Time Frame: 9 weeks ]

Locations (24)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300-
University of California at Los AngelesLos AngelesCalifornia90095-
Stanford University Medical CenterStanfordCalifornia94305-5821-
Christiana Care Health SystemsNewarkDelaware19718-
Georgetown UniversityWashington D.C.District of Columbia20007-
MD Anderson Cancer Center, OrlandoOrlandoFlorida32806-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of Louisville - James Graham Brown Cancer CenterLouisvilleKentucky40202-
Sparrow Regional Cancer CenterLansingMichigan48912-
Mayo Clinic RochesterRochesterMinnesota55905-
Park Nicollet InstituteSaint Louis ParkMinnesota55416-
Washington University School of MedicineSt LouisMissouri63110-
San Juan Oncology AssociatesFarmingtonNew Mexico87401-
St. Luke's Roosevelt Hospital CenterNew YorkNew York10019-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State UniversityColumbusOhio43210-
Providence Portland Medical CenterPortlandOregon97213-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Baylor Sammons Cancer CenterDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-4003-
MultiCare Health SystemTacomaWashington98405-
West Virginia UniversityMorgantownWest Virginia26506-9162-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of California at Los Angeles· Los Angeles, CAStanford University Medical Center· Stanford, CAChristiana Care Health Systems· Newark, DEGeorgetown University· Washington D.C., DCMD Anderson Cancer Center, Orlando· Orlando, FL

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