M16-043 Phase 3 study for patients with treatment naive AML
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Treatment Naïve Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
IRAS ID
225334
Contact name
Gemma - currerntly on maternity leave (08/09/17) Di Iulio
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2016-003900-30
Duration of Study in the UK
2 years, 1 months, 23 days
Research summary
Acute Myeloid Leukaemia (AML) is a cancer of the white blood cells and is the most common form of acute leukaemia in adults. Myeloid cells are a type of white blood cell which perform many functions, including fighting bacterial infections and defending the body against parasites. Acute means that it progresses rapidly and aggressively, which in turn means AML requires immediate treatment.
Young adults diagnosed with AML are considered fit enough for intensive chemotherapy. However, many older patients are classed as unfit for intensive chemotherapy due to age, patients having other co-existing illnesses, and other risk factors. These patients receive less-intensive chemotherapy.
Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to determine if venetoclax added to LDAC, a low-intensity chemotherapy, works better than LDAC alone. Initial results of venetoclax combined with LDAC have been favourable.
This study is for patients with AML, who have not received previous treatment for AML, and are considered unfit for intensive chemotherapy. 2/3 of patients will receive venetoclax daily and LDAC on days 1-10 of each 28 day cycle. 1/3 of patients will receive placebo daily and LDAC on days 1-10 of each 28 day cycle.
Patients will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood and bone marrow, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
REC name
Wales REC 2
REC reference
17/WA/0183
Date of REC Opinion
23 Jun 2017
REC opinion
Favourable Opinion