Phase 2
Completed N=55
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
Hodgkin Disease
Source: ClinicalTrials.gov NCT01874054 ↗
Enrolled (actual)
55
Serious AEs
32.7%
Results posted
Apr 2017
Primary outcomePrimary: Complete Remission Rate — 73.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission Rate |
73.6 | — |
| PRIMARY Incidence of Adverse Events (AEs) |
55; 31; 54; 18; 15; 20 | — |
| SECONDARY Incidence of Dose-limiting Toxicities |
— | — |
| SECONDARY Overall Best Response Rate |
39; 10; 3; 1 | — |
| SECONDARY Duration of Response |
43.0 | — |
| SECONDARY Progression-free Survival |
44.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01874054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.