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Brief Title: Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection
Official Title: 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
Study ID: NCT02836925
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
A.O. Spedali Civili, Brescia, BS, Italy
Irccs Centro Di Riferimento Oncologico (Cro), Aviano, Pordenone, Italy
Ospedale San Bortolo, Vicenza, VI, Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori, Milano, , Italy
Ospedale San Raffaele Ematologia, Milano, , Italy
U.O. Ematologia AO di Padova, Padova, , Italy
A.O. Universitaria Di Parma, Parma, , Italy
Ematologia Policlinico San Matteo, Pavia, , Italy
Ospedale Civile Piacenza, Piacenza, , Italy
Ematologia - Policlinico Umberto I Università Sapienza, Roma, , Italy
Dipartimento di Oncologia Medica ed Ematologia, Istituto Humanitas, Rozzano, , Italy
AOU Città della Salute e della Scienza di Torino, Torino, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Name: Luca Arcaini
Affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
Role: PRINCIPAL_INVESTIGATOR