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Interferons

Sofosbuvir-velpatasvir drug combination

Sofosbuvir

Velpatasvir

Antiviral Agents

Ledipasvir

Ledipasvir, sofosbuvir drug combination

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

Patients with genotype 1 or genotype 4 Ledipasvir 90 mg + Sofosbuvir 400 mg

* 12 weeks in previously untreated infected patients
* 24 weeks for previously treated patients with uncertain subsequent retreatment options

Ledipasvir+Sofosbuvir

Patients with genotype 2 or genotype 3 Sofosbuvir 400 mg + Velpatasvir 100 mg

· 12 weeks of treatment

Sofosbuvir+Velpatasvir

Luca Arcaini

This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).

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.

Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection

A Multicenter Study to Evaluate the Anti-viral Activity of an Interferon-free Treatment With Ledipasvir/Sofosbuvir (G1 and G4) and Sofosbuvir/Velpatasvir (G2 and G3) for Patients With Hepatitis C Virus-associated Indolent B-cell Lymphomas

Sustained virologic response (SVR12) defined as undetectability of HCV-RNA 12 weeks after completion of antiviral therapy

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

Progression-free survival (PFS) defined as the time between enrolment and progression or relapse or death from any cause.

Event-free survival (EFS) defined as time between enrolment and failure of treatment or death as a result of any cause

Overall survival (OS) defined as the time between enrolment and death from any cause

ORR for lymphoma according to Matutes criteria (Matutes et al, Leukemia 2008) only in patients with splenic-marginal zone lymphoma (SMZL)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection	NCT02836925	Indolent B-cell... Hepatitis C	Ledipasvir+Sofo... Sofosbuvir+Velp...	18 Years -	Fondazione Italiana Linfomi - ETS
Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection	NCT02836925	Indolent B-cell... Hepatitis C	Ledipasvir+Sofo... Sofosbuvir+Velp...	18 Years -	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for ledipasvir+sofosbuvir