Acute Myeloid Leukemia, Eltrombopag, Thrombocytopenia
Conditions
Brief summary
Eltrombopag has been used in the treatment of immune thrombocytopenia (ITP), and significantly increased platelet count and decreased fatal hemorrage. As it's known that all patients with acute leukemia will experience bone marrow suppression and thrombocytopenia after chemotherapy. Some patients even died of fatal bleeding during this period for lacking of platelet transfusion or platelet transfusion refractoriness. So a lot needs to be done to shortern thrombocytopenia time or reduce fatal hemorrage incidence after chemotherapy in acute leukemia patients. In this prospective randomized controlled study, the effect and safety of eltrombopag in the treatment of thrombocytopenia after consolidation therapy in acute myeloid leukemia (AML) is evaluated.
Detailed description
Eltrombopag has been used in the treatment of immune thrombocytopenia (ITP), and significantly increased platelet count and decreased fatal hemorrage. As it's known that all patients with acute leukemia will experience bone marrow suppression and thrombocytopenia after chemotherapy. Some patients even died of fatal bleeding during this period for lacking of platelet transfusion or platelet transfusion refractoriness. So a lot needs to be done to shortern thrombocytopenia time or reduce fatal hemorrage incidence after chemotherapy in acute leukemia patients. In this prospective randomized controlled study, the effect and safety of eltrombopag in the treatment of thrombocytopenia after consolidation therapy in acute myeloid leukemia (AML) is evaluated.
Interventions
DRUGEltrombopag
Eltrombopag 25mg bid, starts from the day when platelet count decreases lower than 30×10'9/L, and the treatment lasts for at least 5 days, and stops until platelet count goes up to more than 30×10'9/L, after consolidation therapy in AML patents.
Sponsors
Second Affiliated Hospital, Sun Yat-Sen University
Guangzhou First People's Hospital
Southern Medical University, China
Wuhan General Hospital of Guangzhou Military Command
Third Affiliated Hospital, Sun Yat-Sen University
Dongguan Kanghua Hospital
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
All patients with the age range from 14 to 60 years old with AML exclusive of APL in CR status; All those accepting IA or DA (IDA 10mg or DNR 45mg/m2, d1-3, Ara-C 2g/m2 q12h, d1-3) or MDAC (Ara-C 2g/m2 q12h, d1-3) as consolidation regimens.
Exclusion criteria
Those without obtaining CR; Those experience more 6 cycles of chemotherapy; Any abnormality in a vital sign (e.g., organ function failure, serious infection ); Patients with any conditions not suitable for the trial (investigators' decision).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of fatal hemorrage | 30 days after consolidation therapy. | Fatal hemorrage includes all bleedings have life-threaten to the patients, eg. gastrointestinal bleeding, brain bleeding, pneumorrhagia, etc. |
| Thrombocytopenia time | 30 days after consolidation therapy. | The lasting time for platelet count lower than 20×10'9/L after consolidation therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of thrombus | 30 days after consolidation therapy. | All kinds of thrombus happens in veins and arteries after consolidation therapy. |
Countries
China
Contacts
Primary ContactDan Xu
Outcome results
None listed