Overview

Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML

Status:
Unknown status

Trial end date:
2019-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Nanfang Hospital of Southern Medical University

Collaborators:

Dongguan Kanghua Hospital
Guangzhou First People's Hospital
Second Affiliated Hospital, Sun Yat-Sen University
Southern Medical University, China
Third Affiliated Hospital, Sun Yat-Sen University
Wuhan General Hospital of Guangzhou Military Command

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).