Clinical trial NCT00848926: A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Official title: A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disease, Hodgkin
Keywords: Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Hematologic Diseases
Lymphoma
monomethylauristatin E
Drug Therapy
Immunotherapy
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2009-02-20
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.


Eligibility criteria: Inclusion Criteria:

* Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
* Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
* At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

* Previous treatment with brentuximab vedotin.
* Previously received an allogeneic transplant.
* Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
* History of another primary malignancy that has not been in remission for at least 3 years.
* Known cerebral/meningeal disease.

Primary outcomes:
measure: Objective Response Rate by Independent Review Group
timeFrame: up to 12 months
Secondary outcomes:
measure: Complete Remission Rate by Independent Review Group
timeFrame: up to 12 months
measure: Duration of Objective Response by Kaplan-Meier Analysis
timeFrame: up to approximately 4 years
measure: Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
timeFrame: up to approximately 4 years
measure: Progression-free Survival by Kaplan-Meier Analysis
timeFrame: up to approximately 4 years
measure: Overall Survival
timeFrame: up to approximately 6 years
measure: Adverse Events by Severity, Seriousness, and Relationship to Treatment
timeFrame: up to 12 months
measure: Hematology Laboratory Abnormalities >/= Grade 3
timeFrame: up to 12 months
measure: Chemistry Laboratory Abnormalities >/= Grade 3
timeFrame: up to 12 months
measure: Area Under the Curve
timeFrame: 3 weeks
measure: Maximum Serum Concentration
timeFrame: 3 weeks
measure: Time of Maximum Serum Concentration
timeFrame: 3 weeks
Other outcomes:
measure: B Symptom Resolution
timeFrame: up to 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center Cardinal Bernardin Cancer Center
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Goddine
city: Vancouver
country: Canada
facility: B.C Cancer Agency
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Hospital Saint Louis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Bologna
country: Italy
facility: Instituto di Ematologia ed Oncologia Medica
Study officials:
affiliation: Seagen Inc.
name: Abraham Fong, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.
citation: Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.
citation: Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.