Clinical trial NCT03701217: Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML
Official title: Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Eltrombopag
Thrombocytopenia
Acute Myeloid Leukemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, Sun Yat-Sen University
name: Guangzhou First People's Hospital
name: Southern Medical University, China
name: Wuhan General Hospital of Guangzhou Military Command
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Dongguan Kanghua Hospital
First posted: 2018-10-09
Enrollment: 220
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Thrombocytopenia time
timeFrame: 30 days after consolidation therapy.
measure: The incidence of fatal hemorrage
timeFrame: 30 days after consolidation therapy.
Secondary outcomes:
measure: The incidence of thrombus
timeFrame: 30 days after consolidation therapy.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Dan Xu
role: PRINCIPAL_INVESTIGATOR
References: