FRILLY: a retrospective single center study on Fractionated Rituximab to avoid Lysis Syndrome in Aggressive B-Lymphoma

Lead Investigator: Noémie Lang, University Hospitals of Geneva
Title of Proposal Research: FRILLY: a retrospective single center study on Fractionated Rituximab to avoid Lysis Syndrome in Aggressive B-Lymphoma
Vivli Data Request: 7590
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:
Lymphoma are tumours that originate from white blood cells (B or T), affecting mainly the lymphatic system and represent roughly 2-3% of all cancer type. The pathological classification include Hodgkin and Non Hodgkin lymphoma (NHL), the latter is subdivided into aggressive or indolent lymphoma. Aggressive lymphoma from B cells origin are expressing a CD20 surface marker that could be targeted by a therapeutic antibody named rituximab. Rituximab is a very active drug used in all NHL from B origin nowadays. But its high efficacy may create some complication at first infusion. One of these complications is the occurrence of tumor lysis syndrome (TLS). TLS is a condition that can occur after treatment of a fast-growing cancer, like lymphoma. As the tumor cells die, they break apart and release their contents into the blood. TLS may occur after the first cycle of anti-CD20 antibody and is burdened with significant morbidity and mortality. A local strategy applied in University Hospital of Geneva (HUG) to avoid TLS is to fractionate the first infusion of rituximab over 3 days. We aim to investigate the likelihood to develop and severity of TLS in high-grade B-cell lymphoma patients treated at HUG over the last ten years and how do the fractionated rituximab dose compare to the single rituximab dose.

We are hereby requesting data from clinical studies focusing on newly diagnosed or relapsing B-cell lymphoma patients treated with rituximab administered as a single dose followed by standard chemotherapy, to match our cohort of 70 B-cell lymphoma patients treated with fractionated dose of rituximab (administered over 3 days) at first infusion followed by standard chemotherapy and evaluate the likelihood of developing tumor lysis syndrome (TLS).

We are overall hoping that this study will improve lymphoma patients’ care by better stratify tumor lysis syndrom (TLS) individual-risk and potentially help to improve the design of new preemptive strategies to further reduce the incidence of this life-threatening complication. We choose to perform a matched case-control retrospective study because TLS is a rare event and this design seem to us the best to be applied in this context.

Requested Studies:
A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated
Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Data Contributor: Roche
Study ID: NCT01287741
Sponsor ID: BO21005

A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)
Data Contributor: Roche
Study ID: NCT01649856
Sponsor ID: MO28107

Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas
Data Contributor: Project Data Sphere
Study ID: NCT00118209
Sponsor ID: CALGB-50303