Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Seagen Inc.
Study ID
NCT00655837
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • SGN-40 — DRUG
    4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
  • rituximab — DRUG
    375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
  • gemcitabine — DRUG
    1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.

Study Details

The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Key Dates

Start date
Apr 30, 2008
Status verified
Dec 2014
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab. [ Time Frame: 10 months from registration of last patient ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300-
Mayo Clinic ArizonaScottsdaleArizona85259-
University of ColoradoAuroraColorado80045-0510-
Oncology SpecialistsPark RidgeIllinois60068-
Washington University School of MedicineSt LouisMissouri63110-
Nevada Cancer InstituteLas VegasNevada89135-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALMayo Clinic Arizona· Scottsdale, AZUniversity of Colorado· Aurora, COOncology Specialists· Park Ridge, ILWashington University School of Medicine· St Louis, MONevada Cancer Institute· Las Vegas, NV

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