A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 13 Nov 2019
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At a glance
- Drugs Ibrutinib (Primary) ; Cyclophosphamide; Fludarabine; Rituximab
- Indications Chronic lymphocytic leukaemia
- Focus Therapeutic Use
- 13 Nov 2019 Results published in the Blood.
- 08 Nov 2019 Primary endpoint has been met. (PFS (Progression-free survival)), according to a Janssen media release.
- 08 Nov 2019 According to a Janssen media release, based on the results from this study, the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to expand the IMBRUVICA (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History