Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study (Optimal)
|ClinicalTrials.gov Identifier: NCT02717949|
Recruitment Status : Terminated (failure to recruit)
First Posted : March 24, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease||Drug: sofosbuvir/ledipasvir Drug: sofosbuvir Drug: Ribavirin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study|
|Actual Study Start Date :||February 25, 2016|
|Actual Primary Completion Date :||June 5, 2017|
|Actual Study Completion Date :||July 18, 2017|
sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.
sofosbuvir ledipasvir fixed dose combination given once a day by mouth
Other Name: Harvoni
Experimental: sofosbuvir and ribavirin
Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3
sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally
Other Name: sovaldi
ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg.
- Number Subjects Who Experience Adverse Events on HCV Treatment as Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: from drug dispensation until post-treatment week 36 ]number of subjects who experience treatment-related adverse event on HCV treatment as assessed by DAIDS AE Grading Table version 2.
- Number of Subjects Who Have a Change in Lymph Node Size From Baseline After HCV Treatment [ Time Frame: from baseline to post-treament week 36 ]Number of subjects who have a change in the size of lymph node size from baseline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717949
|United States, New York|
|Cornell Medical Center|
|New York, New York, United States, 10065|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Mamta K. Jain, MD||UT Southwestern Medical Center|