ELASTIC
Research type
Research Study
Full title
A Phase Ib Study of Eltrombopag and Azacitidine in Patients with High Risk Myelodysplastic Syndromes and Related Disorders
IRAS ID
128504
Contact name
Alexander Sternberg
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2013-000341-39
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The ELASTIC trial aims to find the Maximum Tolerated Dose (MTD) of eltrombopag (a drug that increases platelet count) when used with azacitidine (standard therapy) in patients with high risk Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukaemia (CMML-2) and Acute Myeloid Leukaemia (AML) with less than 30% blasts.
Azacitidine has been shown to significantly prolong overall survival in these patients compared with conventional care. However, many patients require dose reductions or dose delays during their azacitidine therapy due to thrombocytopenia (low platelet count) caused by their disease and the azacitidine.
Providing these patients with eltrombopag could maintain a good platelet count which may reduce the number of dose delays and reductions of azacitidine. This would allow patients to receive the optimum dose and schedule of azacitidine.
As these drugs have not been used together before, it is not known what dose of eltrombopag is needed to safely achieve the desired result in platelet count.The trial will recruit between 13-37 patients from 13 Trials Acceleration Programme (TAP) centres and 5 additional centres. The research is funded by Leukaemia and Lymphoma Research with additional education grants from GlaxoSmithKline (GSK) and Celgene for biomarker analysis work.
The MTD will be established using a standard 3+3 cohort design. Once the MTD has been found, an additional 10 patients will be recruited to allow a preliminary estimate of activity.
Patients will follow the UK standard azacitidine visit schedule ( 5 days on, 2 days off, 2 days on) at the start of each cycle and will visit weekly for the remainder of the first 3 cycles (each cycle lasts 4 weeks). Patients will receive blood tests and a physical exam at each visit. Some visits will involve a bone marrow test.
The maximum time the patient will be on study is 25 weeks (6 cycles of azacitidine).REC name
South Central - Oxford C Research Ethics Committee
REC reference
13/SC/0309
Date of REC Opinion
23 Jul 2013
REC opinion
Further Information Favourable Opinion