Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin’s lymphoma: an international, multicentre, single-arm, phase 1–2 trial

Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin’s lymphoma: an international, multicentre, single-arm, phase 1–2 trial
The objective of this study was to explore the safety and clinical activity of brentuximab vedotin plus bendamustine in heavily pretreated patients with relapsed or refractory Hodgkin's lymphoma and anaplastic large T-cell lymphoma.
This was an international, multicentre, single-arm, phase 1-2 trial. Patients with Hodgkin's lymphoma or anaplastic large-T-cell lymphoma who had received at least one previous multi-agent chemotherapy regimen.
The trial occurred in 2 phases:
Phase 1: patients were assigned following a 3+3 dose-escalation design to one of four cohorts to receive brentuximab on day 1 of a 21-day cycle and bendamustine on days 1 and 2 of a 21-day cycle. Outcomes were maximum tolerated dose and dose limiting toxicity.
Phase 2: all patients received brentuximab plus bendamustine at the recommended dose from phase 1.
Complete response was defined as PET negativity.
65 patients were enrolled, most with Hodgkin's lymphoma (n=64). The age range of patients was 18-72 years. 28 patients were evaluated in the phase 1 study and 37 patients were evaluated in the phase 2 study. Maximum tolerated doses were not reached. Dose limiting toxicities included grade 4 neutropenia and diffuse rash. The dose used for phase 2 was the standard dose of each agent when used independently. An overall response was achieved in 29/37 (78%) of patients. Complete response was obtained in 16/37 patients (43%).
6 patients in the phase 1 study and 3 patients in the phase 2 study had progression of disease during treatment (9/65, 14%).
This was a non-randomized trial in a heavily pre-treated group of patients. There are only few patients included in this study. Only adults participated in this study with a range of ages from 18-72 years.
Brentuximab vedotin and bendamustine achieved a clinical response in relapsed and refractory adult patients with Hodgkin's disease.

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