An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 05 Aug 2017
At a glance
- Drugs Acalabrutinib (Primary)
- Indications Mantle-cell lymphoma
- Focus Therapeutic Use
- Sponsors Acerta Pharma
- 01 Aug 2017 According to an AstraZeneca media release, the US FDA has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The FDA granted Breakthrough Therapy Designation based on the totality of clinical data from the acalabrutinib development program, including data from this trial.
- 28 Jul 2017 Planned End Date changed from 1 Jan 2018 to 1 Sep 2019.
- 13 Oct 2016 Planned primary completion date changed from 1 Oct 2016 to 1 Mar 2017.