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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell

Thank you

Trial Information

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas


Inclusion Criteria:



- Patients with newly diagnosed, CD30-positive mature T-cell lymphomas

- Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5
cm by CT

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion Criteria:

- History of another primary invasive malignancy that has not been in remission for at
least 3 years

- Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative
disorders and lymphomas or mycosis fungoides

- History of progressive multifocal leukoencephalopathy (PML)

- Cerebral/meningeal disease related to the underlying malignancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival per independent review facility (IRF)

Outcome Time Frame:

Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment

Safety Issue:

No

Principal Investigator

Dana Kennedy, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-014

NCT ID:

NCT01777152

Start Date:

January 2013

Completion Date:

December 2019

Related Keywords:

  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD30
  • Drug Therapy
  • Hematologic Diseases
  • Lymphoma
  • Immunotherapy
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, Large-Cell, Anaplastic
  • Monomethyl auristatin E
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic

Name

Location
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Washington University School of Medicine Saint Louis, Missouri  63110
MD Anderson Cancer Center Orlando Orlando, Florida  32806
Virginia Mason Medical Center Seattle, Washington  98111
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Rochester Medical Center Rochester, New York  14642
Hackensack University Medical Center Hackensack, New Jersey  07601
Charles A. Sammons Cancer Center Dallas, Texas  75246
Yale Cancer Center New Haven, Connecticut  06520-8028
Stanford Cancer Center Stanford, California  94305-5824
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
University of Maryland Baltimore, Maryland  21201
Columbia University Medical Center New York, New York  10032
Sarah Cannon Research Institute Nashville, Tennessee  37203
Park Nicollet Institute St Louis Park, Minnesota  55416
Weill Cornell Medical College New York, New York  10021
Montefiore Medical Center/Albert Einstein College of Medicine Bronx, New York  10461
Georgia Health Sciences University Augusta, Georgia  30912
Cleveland Clinic, The Cleveland, Ohio  44195
Virginia Commonwealth University Medical Center Richmond, Virginia  23298
MD Anderson Cancer Center /The University of Texas Houston, Texas  77030
Providence St Joseph Medical Center Burbank, California  91505
Jewish Hospital, The Cincinnati, Ohio  45236