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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
Patients with genotype 2 or genotype 3 Sofosbuvir 400 mg + Velpatasvir 100 mg · 12 weeks of treatment
A.O. Spedali Civili
Brescia, BS, Italy
Irccs Centro Di Riferimento Oncologico (Cro)
Aviano, Pordenone, Italy
Ospedale San Bortolo
Vicenza, VI, Italy
SVR12
Sustained virologic response (SVR12) defined as undetectability of HCV-RNA 12 weeks after completion of antiviral therapy
Time frame: 12 weeks from the end of the treatment
ORR
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
Time frame: 12 weeks from the end of treatment
PFS
Progression-free survival (PFS) defined as the time between enrolment and progression or relapse or death from any cause.
Time frame: 36 months
EFS
Event-free survival (EFS) defined as time between enrolment and failure of treatment or death as a result of any cause
Time frame: 36 months
OS
Overall survival (OS) defined as the time between enrolment and death from any cause
Time frame: 36 months
ORR for lymphoma
ORR for lymphoma according to Matutes criteria (Matutes et al, Leukemia 2008) only in patients with splenic-marginal zone lymphoma (SMZL)
Time frame: 12 weeks from the end of treatment
Rapid virological response
rapid virologic response (RVR)
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Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milan, Italy
Ospedale San Raffaele Ematologia
Milan, Italy
U.O. Ematologia AO di Padova
Padua, 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
...and 3 more locations
Time frame: 4 weeks
Extended rapid virological response
extended RVR (eRVR)
Time frame: 4 weeks
Early virological response
early virologic response (EVR)
Time frame: 4 weeks
Toxicity - Incidence of Adverse Events
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
Time frame: 12 months