Refractory Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Study of Brentuximab Vedotin as Salvage Therapy for Hodgkin Lymphoma Prior to Autologous Hematopoietic Stem Cell Transplantation
This phase II trial studies how well brentuximab vedotin before autologous (taken from an individual's own cells) stem cell transplant works in treating patients with Hodgkin lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells.
PRIMARY OBJECTIVES:
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).
SECONDARY OBJECTIVES:
I. To describe the safety, toxicity, and tolerability of brentuximab vedotin as a salvage
regimen.
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 as first line salvage therapy.
IV. To examine and characterize the outcomes of patients who receive brentuximab vedotin as
first line salvage followed by autologous hematopoietic stem cell transplantation (AHCT)
(e.g., toxicity, 2-year progression free survival [PFS], overall survival [OS],
relapse-progression incidence and non-relapse mortality rate [NRM])
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment
repeats every 21 days for up to 4 courses.
Patients in the new cohort receive regular study dose of brentuximab vedotin for courses 1
and 2. Patients not achieving complete remission (CR) after 2 courses receive higher-dose
brentuximab vedotin IV over 60 minutes on day 1 for 2 additional courses.
After completion of study treatment, patients are followed up at 21 days.
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