Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701217
• Other study ID #: Eltrombopag-AML-2018
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 10, 2018
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Dan Xu
• Phone: +86-20-61641615
• Email: xudan2[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Eltrombopag
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Thrombocytopenia

Intervention

Drug:
• Eltrombopag
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.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombocytopenia time	The lasting time for platelet count lower than 20×10`9/L after consolidation therapy.	30 days after consolidation therapy.
Primary	The incidence of fatal hemorrage	Fatal hemorrage includes all bleedings have life-threaten to the patients, eg. gastrointestinal bleeding, brain bleeding, pneumorrhagia, etc.	30 days after consolidation therapy.
Secondary	The incidence of thrombus	All kinds of thrombus happens in veins and arteries after consolidation therapy.	30 days after consolidation therapy.