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)
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Seagen Inc.
- Enrollment
- 55
- Locations
- 13
- Primary Endpoint
- Incidence of Adverse Events (AEs)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Brentuximab Vedotin + 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
Intervention: brentuximab vedotin (Drug)
Brentuximab Vedotin + 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
Intervention: bendamustine (Drug)
Outcomes
Primary Outcomes
Incidence of Adverse Events (AEs)
Time Frame: 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
Time Frame: 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 Outcomes
- Overall Best Response Rate(Up to 4.6 months)
- Duration of Response(Up to 47.8 months)
- Incidence of Dose-limiting Toxicities(Up to 3 weeks; first cycle of therapy through the first day of Cycle 2)
- Progression-free Survival(Up to 49 months)