NCT02836925

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Indolent B-cell Lymphoma
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Ledipasvir+Sofosbuvir	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
DRUG	Sofosbuvir+Velpatasvir	Patients with genotype 2 or genotype 3 Sofosbuvir 400 mg + Velpatasvir 100 mg · 12 weeks of treatment

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-02-01
• Completion: 2022-11-01
• First posted: 2016-07-19
• Last updated: 2023-03-31

Locations

13 sites across 1 country: Italy