A Phase 1/2 Study of Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy
Active, no longer recruiting
Phase of Trial: Phase I/II
Latest Information Update: 01 Nov 2017
At a glance
- Drugs Venetoclax (Primary) ; Cytarabine
- Indications Acute myeloid leukaemia
- Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
- Sponsors AbbVie
- 01 Nov 2017 According to a Genentech media release, data from the study will be presented at the American Society of Hematology (ASH) 2017 Annual Meeting.
- 28 Jul 2017 According to a Roche media release, the US FDA has granted breakthrough therapy designation for Venclexta (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy. The designation was granted based on data from this trial.
- 25 Jun 2017 Updated safety and efficacy results from the RP2D 600-mg dose cohorts (n=61, data cut-off Aug 2016) of this study, presented at the 22nd Congress of the European Haematology Association.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History