A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
Status: Active, no longer recruiting
Phase of Trial: Phase I/II
Latest Information Update: 16 Jun 2019
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At a glance
- Drugs Venetoclax (Primary) ; Azacitidine; Azacitidine; Rituximab
- Indications Acute myeloid leukaemia; Chronic lymphocytic leukaemia; Multiple myeloma; Non-Hodgkin's lymphoma
- Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
- Sponsors AbbVie
- 19 Mar 2019 According to an AbbVie media release, the company announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax for the investigational treatment of multiple myeloma. The partial clinical hold follows a review of data from BELLINI study.As a result of this action, no new patients should be enrolled in any studies of venetoclax for multiple myeloma until a further analysis of the data is completed.
- 29 Mar 2018 Status changed from recruiting to active, no longer recruiting.
- 14 Feb 2018 Planned number of patients changed from 36 to 37.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History