Clinical trial NCT01874054: Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
Official title: A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hodgkin Disease
Keywords: Antibody-Drug Conjugate
Antibodies, Monoclonal
Hodgkin Disease
Hematologic Diseases
Drug Therapy
Immunotherapy
Antigens, CD30
Lymphoma
monomethylauristatin E
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-10
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.


Eligibility criteria: Inclusion Criteria:

* Histopathological diagnosis of classical Hodgkin lymphoma
* Failed standard front-line therapy
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group performance status less than or equal to 2

Exclusion Criteria:

* Received prior salvage therapy, including radiotherapy
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* Concurrent use of other investigational agents

Primary outcomes:
measure: Complete Remission Rate
timeFrame: Up to 4.6 months
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 13.8 months
Secondary outcomes:
measure: Incidence of Dose-limiting Toxicities
timeFrame: Up to 3 weeks; first cycle of therapy through the first day of Cycle 2
measure: Overall Best Response Rate
timeFrame: Up to 4.6 months
measure: Duration of Response
timeFrame: Up to 47.8 months
measure: Progression-free Survival
timeFrame: Up to 49 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: Pacific Hematology Oncology Associates
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Whittier
country: United States
facility: Oncology Institute of Hope & Innovation, The
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Jewish Hospital, The
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University / University Hospitals Case Medical Center
state: Ohio
city: Greenville
country: United States
facility: Saint Francis Hospital / Bon Secours
state: South Carolina
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center / Baylor University Medical Center
state: Texas
Study officials:
affiliation: Seagen Inc.
name: Neil Josephson, MD
role: STUDY_DIRECTOR
References:
citation: LaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27.