Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study
Status:
Terminated
Trial end date:
2017-07-18
Target enrollment:
Participant gender:
Summary
There still remains the question if hepatitis C eradication with all oral therapy will lead
to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that
oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate
with a reduction of the size and extent of low-grade lymphoma. The hypothesis of this study
is that subjects with hepatitis C,regardless of genotype, who have low grade lymphoma, when
treated for hepatitis C without pegylated interferon will have a regression of low grade
non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of
Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a
subset of HCV-related low grade B cell non-Hodgkin's lymphoma
Primary Objective This study will assess the safety, as measured by adverse events, in
subjects receiving hepatitis C treatment.
Secondary Objective The secondary objective of this study is to assess the rate of overall
response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete
response according to revised international working group criteria for non-Hodgkin lymphoma.
Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in
subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and
serious adverse events. In addition, the study will assess the number of subjects who had to
stop treatment due to adverse events or serious adverse events. The study will also examine
the number of subjects in which treatment for lymphoma had to be given due to clinical
progression.
Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of
overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or
complete response according to revised international working group criteria for non-Hodgkin
lymphoma. (2) Determine the rate of sustained viral response in subjects with low-grade
lymphoma.
Phase:
Phase 4
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Memorial Sloan Kettering Cancer Center Weill Medical College of Cornell University