Eltrombopag for MDS patients21 Aug. 2016
Research FOR Patients
-For an informed and empowered opinion-
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- SUB-TYPE OF MDS: MDS patients who are platelet transfusion dependent
- SEVERITY OF MDS: intermediate 1 & 2 or high risk
- NAME OF DRUG: Eltrombopag, Promacta™/Revolade™
- Aims and benefits: Study will assess the proportion of patients who are platelet transfusion free during the first four cycles of treatment
- For: Platelet transfusion dependant MDS patients.
IPSS: Intermediate-1, intermediate-2 or high risk patients with MDS
How: Phase III study - eltrombopag + azacitidine vs placebo + azacitidine
Eligible patients will be randomised to receive either option - for at least 6 cycles:
- eltrombopag (200 mg once daily) + azacitidine
- placebo plus azacitidine
(azacitidine is given as subcutaneous injections once daily for 7 days, every 28 days)
Main aim : Study will assess the platelet supportive care effects of eltrombopag - by veryfying which group of patients will be platelet transfusion free during the first four cycles of treatment.
Secondary aim: compare the 2 treatment groups in regards to
platelet and red blood cell transfusions,
safety and tolerability,
health related quality of life and
medical resource utilization
- Main basic inclusion criteria: Platelet transfusion dependent MDS patients
- Main basic exclusion criteria: tbc
- Trial sites/locations and name of physician in charge of trial:
- More information: https://clinicaltrials.gov/ct2/show/NCT01286038
Please read information and always discuss trial information with your own physician.