Know Cancer

or
forgot password

A Phase 2, Single-arm, Open-label Study of Single-agent Brentuximab Vedotin for Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above


Phase 2
60 Years
N/A
Open (Enrolling)
Both
Hodgkin Disease

Thank you

Trial Information

A Phase 2, Single-arm, Open-label Study of Single-agent Brentuximab Vedotin for Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above


Inclusion Criteria:



- Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma

- Ineligible for or have declined initial conventional chemotherapy

- Measurable disease of at least 1.5 cm as documented by radiographic technique

- ECOG performance status less than or equal to 3

Exclusion Criteria:

- Symptomatic neurologic disease compromising instrumental activities of daily living
or requiring medication

- Concurrent use of other investigational agents

- Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not
completed 4 weeks prior to first dose of study drug

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

Through 1 month following last dose

Safety Issue:

No

Principal Investigator

Megan O'Meara, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-015

NCT ID:

NCT01716806

Start Date:

October 2012

Completion Date:

June 2016

Related Keywords:

  • Hodgkin Disease
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Hematologic Diseases
  • Hodgkin Disease
  • Antigens, CD30
  • Lymphoma
  • monomethylauristatin E
  • Drug Therapy
  • Immunotherapy
  • Hodgkin Disease
  • Lymphoma

Name

Location

University of Rochester Medical CenterRochester, New York  14642
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
City of HopeDuarte, California  91010
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Columbia University Medical CenterNew York, New York  10032
Northwest Cancer Specialists, P.C.Portland, Oregon  97227
Rocky Mountain Cancer Centers - AuroraAurora, Colorado  80012
Nebraska Cancer SpecialistsOmaha, Nebraska  68114
Illinois Cancer SpecialistsNiles, Illinois  60714
Arizona Oncology Associates, PC - HOPETucson, Arizona  85704
Virginia Commonwealth University Medical CenterRichmond, Virginia  23298
Texas Oncology - Seton WilliamsonRound Rock, Texas  78665
Willamette Valley Cancer and Research / USOREugene, Oregon  97401
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer CareChristianburg, Virginia  24073
Providence St Joseph Medical CenterBurbank, California  91505
Georgia Cancer Specialists - Admin AnnexAtlanta, Georgia  30341