Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
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)
1 other identifier
interventional
55
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2013
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedResults Posted
Study results publicly available
April 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2018
CompletedFebruary 12, 2019
January 1, 2019
2.5 years
June 6, 2013
December 22, 2016
January 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete Remission Rate
Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
Up to 4.6 months
Incidence of Adverse Events (AEs)
All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.
Up to 13.8 months
Secondary Outcomes (4)
Incidence of Dose-limiting Toxicities
Up to 3 weeks; first cycle of therapy through the first day of Cycle 2
Overall Best Response Rate
Up to 4.6 months
Duration of Response
Up to 47.8 months
Progression-free Survival
Up to 49 months
Study Arms (1)
Brentuximab Vedotin + Bendamustine
EXPERIMENTALBrentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
Interventions
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (13)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Pacific Hematology Oncology Associates
San Francisco, California, 94115, United States
Stanford Cancer Center
Stanford, California, 94305, United States
Oncology Institute of Hope & Innovation, The
Whittier, California, 90603, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic Minnesota
Rochester, Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Columbia University Medical Center
New York, New York, 10022, United States
Jewish Hospital, The
Cincinnati, Ohio, 45236, United States
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, 29601, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246, United States
Related Publications (1)
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.
PMID: 29703778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seattle Genetics, Inc.
Study Officials
- STUDY DIRECTOR
Neil Josephson, MD
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 10, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2015
Study Completion
February 20, 2018
Last Updated
February 12, 2019
Results First Posted
April 6, 2017
Record last verified: 2019-01