An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL.
Active, no longer recruiting
Phase of Trial: Phase I
Latest Information Update: 17 Jul 2017
At a glance
- Drugs Rituximab (Primary) ; Rituximab (Primary) ; Cyclophosphamide; Fludarabine
- Indications Chronic lymphocytic leukaemia
- Focus Pharmacokinetics
- Acronyms SAWYER
- Sponsors Roche
- 22 Jun 2017 Based on the data from NCT01200758, NCT01292603, NCT01649856 and NCT01724021 studies, U.S. FDA approved RITUXAN HYCELA for subcutaneous injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously chronic lymphocytic leukemia (CLL).
- 10 Jun 2017 Biomarkers information updated
- 29 Mar 2017 According to a Halozyme Therapeutics media release, an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration has provided unanimous recommendation for subcutaneous rituximab coformulated with Halozyme Enhanze Technology. The FDA action date is June 26, 2017. Data from this study supported the application.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History