A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Seagen Inc.
Study ID
NCT01421667
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • brentuximab vedotin — DRUG
    1.8 mg/kg every 3 weeks by IV infusion
  • rituximab — DRUG
    375 mg/m2 every 3 weeks by IV infusion

Study Details

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Key Dates

Start date
Aug 31, 2011
Status verified
Jun 2015
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
176 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brentuximab vedotin+rituximab
  • Experimental: Brentuximab vedotin

Primary Outcome Measure

Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy [ Time Frame: Up to approximately 3 years ]

Locations (33)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300-
City of HopeDuarteCalifornia91010-3000-
PMK Medical Group Inc., DBA Ventura County Hematology Oncology SpecialistsOxnardCalifornia93030-
Stanford Cancer CenterStanfordCalifornia94305-5821-
Rocky Mountain Cancer Centers - AuroraAuroraColorado80012-
Colorado Blood Cancer InstituteDenverColorado80218-
Cancer Specialists of North Florida - St. AugustineSaint AugustineFlorida32086-
Emory Winship Cancer InstituteAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60637-1470-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Minnesota Oncology Hematology P.A.MinneapolisMinnesota55404-
Washington University School of MedicineSt LouisMissouri63110-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Hackensack University Medical CenterHackensackNew Jersey07601-
New York Oncology Hematology, P.C.AlbanyNew York12206-
Columbia University Medical CenterNew YorkNew York10019-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
NYU Clinical Cancer CenterNew YorkNew York10016-
Cleveland Clinic, TheClevelandOhio44195-
Willamette Valley Cancer and Research / USOREugeneOregon97401-
Medical University of South CarolinaCharlestonSouth Carolina29425-
St. Francis HospitalGreenvilleSouth Carolina29605-
Charles A. Sammons Cancer CenterDallasTexas75246-
Texas Oncology - Medical City DallasDallasTexas75230-
Texas Oncology-Southwest Fort WorthFort WorthTexas76132-
MD Anderson Cancer Center / University of TexasHoustonTexas77030-4003-
Texas Oncology - Seton WilliamsonRound RockTexas78665-
Texas Oncology - TylerTylerTexas75702-
Virginia Cancer Specialists, PCFairfaxVirginia22031-
Swedish Cancer Institute Medical OncologyEdmondsWashington98026-
Seattle Cancer Care Alliance / University of Washington Medical CenterSeattleWashington98109-
Northwest Cancer Specialists, P.C.VancouverWashington98684-

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