Eltrombopag therapy for low platelets in patients on azacitidine treatment for myelodysplastic syndrome and acute myeloid leukaemia
- Conditions
- Myelodysplastic Syndromes (MDS)Cancer - Leukaemia - Acute leukaemiaLow marrow blast count acute myeloid leukaemia (AML)Blood - Haematological diseases
- Registration Number
- ACTRN12610000641099
- Lead Sponsor
- Peter Mac Callum Cancer Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Patients with low platelet count (<=150 x109/L) and in addition disease diagnosis of either MDS (by World Health Organization Criteria, those with refractory anemia with high blast counts and refractory anemia with ringed sideroblasts to also have at least one clinically significant cytopenia), nonproliferative Chronic Myelomonocytic Leukaemia (CMML) or low marrow blast count AML not suitable for induction chemotherapy; Eastern Cooperative Oncology Group (ECOG) 2 or less with life expectancy at least 3 months, adequate contraception and adequate renal and hepatic function; written informed consent
Subjects with the diagnosis acute promyelocytic leukaemia; Prior treatment with 5-azacitidine or any other methyl-transferase inhibitor, eltrombopag, romiplostim, or other Trombopoietin T (TPO)-receptor agonist;AML or MDS requiring cytoreductive therapy (eg hydroxyurea, ara-c, thioguanine etc) in the month prior to study entry; known pro-thrombotic condition; history of Ischaemic neurological event (Transient Ischaemic Attack (TIA) or stroke) within the preceding 2 years;active or uncontrolled infections
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grade III/IV non-haematological toxicity possibly, probably or definitely related to the combination of eltrombopag and azacitidine based on clinical assessments.[At 6 cycles of therapy (approx 6 months)]
- Secondary Outcome Measures
Name Time Method Secondary outcome 1:<br>To gather preliminary evidence of the clinical efficacy of eltrombopag to improve platelet counts in this setting, and the appropriate dose at which this may be achieved based on data obtained from clinical assessments, up to 4 bone marrow biopsies, and peripheral blood tests.[Time point: approximately 2.5 years after the last accrued patient completes study treatment];To explore laboratory findings to correlate with the response of the combination of 5-azacitidine and eltrombopag in patients with MDS and low marrow blast count AML[Time point: approximately 2.5 years after last accrued patient completes study treatment]