A Phase II Study of Brentuximab Vedotin as Salvage Therapy for Hodgkin Lymphoma Prior to Autologous Hematopoietic Stem Cell Transplantation
I. The primary objective of this study is to determine the activity of salvage brentuximab
vedotin in Hodgkin lymphoma prior to autologous hematopoietic stem cell transplantation, as
measured by overall response rate (ORR).
I. To describe the safety, toxicity, and tolerability of brentuximab vedotin as a salvage
II. To summarize the stem cell mobilization results of patients receiving brentuximab
vedotin as salvage therapy (e.g., total cluster of differentiation (CD)34+ cell yield,
number of apheresis days, proportion of patients who achieve >= 3 x 10^6 CD34+ cells/kg).
III. To evaluate potential changes in Hodgkin lymphoma biological markers of patients
treated with brentuximab vedotin.
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment
repeats every 21 days for up to 4 courses.
After completion of study treatment, patients are followed up at 21 days.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of this salvage brentuximab vedotin treatment for Hodgkin lymphoma before autologous hematopoietic stem cell transplantation
Measured by the overall response rate (ORR). The study will utilize a Simon two-stage optimal design. Response rates will be calculated as the percent of evaluable patients that have confirmed complete response (CR) or partial response (PR) by radiographic response including CT and/or PET scans, and exact 95% confidence intervals will be calculated for this estimate. Time to response, duration of response, and survival will be estimated using the product-limit method of Kaplan and Meier.
21 days after completion of last course of study treatment
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|
|Weill Medical College, Cornell University||New York, New York 10021|