SGI-110 vs Treatment Choice in Adults with Previously Treated AML
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Previously Treated Acute Myeloid Leukemia
IRAS ID
223815
Contact name
Christopher Pocock
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2015-005256-97
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 4 days
Research summary
‘Acute myeloid leukaemia (AML) is the most common acute leukaemia diagnosed in adults and carries high morbidity rates. The American Cancer Society estimated that 19,950 new cases of AML will be diagnosed in 2016 and approximately 10,430 will die from their disease. The average age of a patient with AML is about 67 years; AML is generally a disease of older people and is uncommon before age 45.
In AML, myeloblasts (immature cell of the bone marrow) crowd out normal blood cells in the bone marrow, leaving the patient with insufficient red blood cells, platelets, and neutrophils (white blood cells). The Jack of these cells cause most of the symptoms of leukaemia. Diagnosis of AML requires a rapid assessment and initiation of treatment. AML leads to death within a few weeks to months after diagnosis if left untreated.
The purpose of the study is to test how effective and safe guadecitabine is compared with current standard treatment for AML. Patients who are found to be eligible for the study will be consented and they will follow the course of the study for approximately 26 months.
Participants will be randomised to receive either Guadecitabine or "Treatment Choice": one of several treatments that are usually prescribed for adults with AML after they received standard treatments that either did not work or did not continue to provide benefit, in a 1:1 ratio.The study drug guadecitabine will be given by a subcutaneous injection(under the skin). The dose of guadecitabine will be 60 mg/m2 of body surface area and the correct dose for each patient will be determined by the study doctor. Guadecitabine is given on a 28 day treatment cycle.
This is a Multicentre, randomised, open-label, parallel-group study of guadecitabine vs TC in patients with AML.'
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0151
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion