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dc.contributor.authorLim, SH
dc.contributor.authorLinton, Kim M
dc.contributor.authorCollins, GP
dc.contributor.authorDhondt, J
dc.contributor.authorCaddy, J
dc.contributor.authorRossiter, L
dc.contributor.authorVadher, K
dc.contributor.authorFines, K
dc.contributor.authorRogers, LE
dc.contributor.authorFernando, D
dc.contributor.authorStanton, L
dc.contributor.authorDavies, AJ
dc.contributor.authorJohnson, PWM
dc.contributor.authorGriffiths, G
dc.date.accessioned2018-12-10T11:48:55Z
dc.date.available2018-12-10T11:48:55Z
dc.date.issued2018en
dc.identifier.citationLim SH, Linton KM, Collins GP, Dhondt J, Caddy J, Rossiter L, et al. RIVA - a phase IIa study of rituximab and varlilumab in relapsed or refractory B-cell malignancies: study protocol for a randomized controlled trial. Trials. 2018 Nov 9;19(1):619.en
dc.identifier.pmid30413184en
dc.identifier.doi10.1186/s13063-018-2996-6en
dc.identifier.urihttp://hdl.handle.net/10541/621412
dc.description.abstractBACKGROUND: Over 12,000 new cases of B-cell malignancies are diagnosed in the UK each year, with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) being the most common subtypes. Standard frontline therapy consists of immunochemotherapy with a CD20 monoclonal antibody (mAb), such as rituximab, delivered in combination with multi-agent chemotherapy. Despite being considered a treatable and potentially curable cancer, approximately 30% of DLBCL cases will relapse after frontline therapy. Advanced stage FL is incurable and typically has a relapsing and remitting course with a frequent need for re-treatment. Based on supportive preclinical data, we hypothesised that the addition of varlilumab (an anti-CD27 mAb) to rituximab (an anti-CD20 mAb) can improve the rate, depth and duration of the response of rituximab monotherapy in patients with relapsed or refractory B-cell malignancies. METHODS/DESIGN: Combination treatment of varlilumab plus rituximab, in two different dosing regimens, is being tested in the RIVA trial. RIVA is a two-stage open-label randomised phase IIa design in up to 40 patients with low- or high-grade relapsed or refractory CD20+ B-cell lymphoma. The study is open to recruitment in the UK. Enrolled patients are randomised 1:1 to two different experimental varlilumab to rituximab combinations. The primary objective is to determine the safety and tolerability of the combination and the anti-tumour activity (response) in relapsed or refractory B-cell malignancies. Secondary objectives will include an evaluation of the duration of the response and overall survival. Tertiary translational objectives include assessment of B-cell depletion, changes in immune effector cell populations, expression of CD27 as a biomarker of response and pharmacokinetic properties. Analyses will not be powered for formal statistical comparisons between treatment arms. DISCUSSION: RIVA will determine whether the combination of rituximab and varlilumab in relapsed or refractory B-cell malignancies is active and safe prior to future phase II/III trials. TRIAL REGISTRATION: EudraCT, 2017-000302-37. Registered on 16 January 2017. ISRCTN, ISRCTN15025004 . Registered on 16 August 2017.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1186/s13063-018-2996-6en
dc.titleRIVA - a phase IIa study of rituximab and varlilumab in relapsed or refractory B-cell malignancies: study protocol for a randomized controlled trial.en
dc.typeArticleen
dc.contributor.departmentAntibody and Vaccine Group, Centre for Cancer Immunology, University of Southampton, Southampton, UKen
dc.identifier.journalTrialsen


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