NCT02717949: Optimal

Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study

Terminated Phase 4 Results posted Last updated 8 January 2019

What this trial tests

Phase 4 trial testing sofosbuvir/ledipasvir in Liver Disease in 1 participant. Terminated before completion.

Timeline

25 February 2016

Primary endpoint
5 June 2017

18 July 2017

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	25 February 2016
Primary completion	5 June 2017
Estimated completion	18 July 2017
Sites	3 locations across United States

Drugs / interventions tested

• sofosbuvir/ledipasvir — full drug profile →
• sofosbuvir — full drug profile →
• Ribavirin — full drug profile →

Conditions studied

• Liver Disease — all drugs for Liver Disease →

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, any sex, with Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Molecular mechanisms of viral oncogenesis in haematological malignancies: perspectives from metabolic reprogramming, epigenetic regulation and immune microenvironment remodeling.
   Xiao Q, Liu Y, Shu X, Li Y, et al · · 2025 · cited 9× · PMID 40349096 · DOI 10.1186/s40164-025-00655-2