Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
- Registration Number
- NCT01874054
- Lead Sponsor
- Seagen Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brentuximab Vedotin + Bendamustine brentuximab vedotin Brentuximab 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 Brentuximab Vedotin + Bendamustine bendamustine Brentuximab 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
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 13.8 months 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.
Complete Remission Rate Up to 4.6 months 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.
- Secondary Outcome Measures
Name Time Method Duration of Response Up to 47.8 months The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.
Overall Best Response Rate Up to 4.6 months Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma
Incidence of Dose-limiting Toxicities Up to 3 weeks; first cycle of therapy through the first day of Cycle 2 Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.
Progression-free Survival Up to 49 months The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
Trial Locations
- Locations (13)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Saint Francis Hospital / Bon Secours
🇺🇸Greenville, South Carolina, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Oncology Institute of Hope & Innovation, The
🇺🇸Whittier, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Pacific Hematology Oncology Associates
🇺🇸San Francisco, California, United States
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Case Western Reserve University / University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Jewish Hospital, The
🇺🇸Cincinnati, Ohio, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
🇺🇸Dallas, Texas, United States