Clinical Trial: Sofosbuvir+Ledipasvir ±Ribavirin and Sofosbuvir+Ribavirin for Pts With Indolent Bcell Lymphoma Associated With HCV Infection Treatment With Sofosbuvir Plus Ledipasvir ± Ribavirin(G1, 3 and 4) and Sofosbuvir+Ribavirin(G2) for Pts With Hepatitis C Virus Associated Indolent B-cell Lymphomas
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multicenter Study to Evaluate the Anti-viral Activity of an Interferonfree Treatment With Sofosbuvir Plus Ledipasvir ± Ribavirin(G1, 3 and 4)and Sofosbuvir+Ribavirin(G2)for Pts With Hepatitis C
Brief Summary: This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir ± ribavirin (genotype 1, 3 and 4) or sofosbuvir + ribavirin (genotype 2) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).
Detailed Summary: The study includes an antiviral treatment with interferon-free regimen followed by lymphoma restaging; following the end of antiviral treatment patients will be evaluated for sustained virological response and safety parameters every 3 months for 1 year and then every 6 months for 2 years. ORR and vital status will be also evaluated.
Sponsor: Fondazione Italiana Linfomi ONLUS
Current Primary Outcome: SVR12 [ Time Frame: 12 weeks from the end of the treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- ORR [ Time Frame: 12 weeks from the end of treatment ]Overall response rate (ORR) of lymphoma: CR is defined by the complete disappearance of all detectable sites and symptoms; PR is defined as a more than 50% reduction. Responses different from CR/PR are defined as stable disease (SD); progressive disease (PD) is considered an increase in size of more than 50% of previously documented disease or the appearance of new lesions. Lymphoma response will be assessed 12 weeks after the end of antiviral treatment
- PFS [ Time Frame: 36 months ]Progression‐free survival (PFS) defined as the time between enrolment and progression or relapse or death from any cause.
- EFS [ Time Frame: 36 months ]Event‐free survival (EFS) defined as time between enrolment and failure of treatment or death as a result of any cause
- OS [ Time Frame: 36 months ]Overall survival (OS) defined as the time between enrolment and death from any cause
- ORR for lymphoma [ Time Frame: 12 weeks from the end of treatment ]ORR for lymphoma according to Matutes criteria (Matutes et al, Leukemia 2008) only in patients with splenic-marginal zone lymphoma (SMZL)
- Rapid virological response [ Time Frame: 4 weeks ]rapid virologic response (RVR)
- Extended rapid virological response [ Time Frame: 4 weeks ]extended RVR (eRVR)
- Early virological response [ Time Frame: 4 weeks ]early virologic response (EVR)
- Toxicity - Incidence of Adverse Events [ Time Frame: 12 months ]toxicity will be classified according to definitions of Common Terminology Criteria for Adverse Event version 4.03 (CTCAE). It will be determined by the incidence of severe, life‐threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events
Original Secondary Outcome:
- ORR [ Time Frame: 12 weeks from the end of treatment ]Overall response rate (ORR) of lymphoma: CR is defined by the complete disappearance of all detectable sites and symptoms; PR is defined as a more than 50% reduction. Responses different from CR/PR are defined as stable disease (SD); progressive disease (PD) is considered an increase in size of more than 50% of previously documented disease or the appearance of new lesions. Lymphoma response will be assessed 12 weeks after the end of antiviral treatment
- PFS [ Time Frame: 36 months ]Progression‐free survival (PFS) defined as the time between enrolment and progression or relapse or death from any cause.
- EFS [ Time Frame: 36 months ]Event‐free survival (EFS) defined as time between enrolment and failure of treatment or death as a result of any cause
- OS [ Time Frame: 36 months ]Overall survival (OS) defined as the time between enrolment and death from any cause
- ORR for lymphoma [ Time Frame: 12 weeks from the end of treatment ]ORR for lymphoma according to Matutes criteria (Matutes et al, Leukemia 2008) only in patients with splenic-marginal zone lymphoma (SMZL)
- Rate of virological response [ Time Frame: 4 weeks ]rapid virologic response (RVR)
- Rate of virological response [ Time Frame: 4 weeks ]extended RVR (eRVR)
- Rate of virological response [ Time Frame: 4 weeks ]early virologic response (EVR)
- Toxicity - Incidence of Adverse Events [ Time Frame: 12 months ]toxicity will be classified according to definitions of Common Terminology Criteria for Adverse Event version 4.03 (CTCAE). It will be determined by the incidence of severe, life‐threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events
Information By: Fondazione Italiana Linfomi ONLUS
Dates:
Date Received: February 25, 2016
Date Started: March 2016
Date Completion: October 2020
Last Updated: March 24, 2017
Last Verified: September 2016