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.

Trial Profile

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.

Completed
Phase of Trial: Phase I

Latest Information Update: 22 Mar 2018

At a glance

  • Drugs Rituximab (Primary) ; Rituximab (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Chronic lymphocytic leukaemia
  • Focus Pharmacokinetics
  • Acronyms SAWYER
  • Sponsors Roche
  • Most Recent Events

    • 22 Mar 2018 According to an Roche Canada media release, Health Canada has approved RITUXAN(rituximab) subcutaneous (SC) for the treatment of patients with previously untreated or previously treated B-cell chronic lymphocytic leukemia (B-CLL).
    • 22 Mar 2018 Results presented in the Roche Canada media release.
    • 15 Dec 2017 Status changed from active, no longer recruiting to completed.
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