Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia; Thrombocytopenia; Eltrombopag
• Intervention / Treatment: Drug: Eltrombopag

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.

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Department of Hematology,Nanfang Hospital, Southern Medical University
      • Contact: Dan Xu; Phone Number: +86-20-61641615; Email: xudan2@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eltrombopag treatment; 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. Platelet transfusion application is routinely done when platelet count is lower than 20×10'9/L or active hemorrage happens to patients.	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.
Active Comparator: Eltrombopag free; Eltrombopag treatment is not performed in this group. Platelet transfusion application is routinely done when platelet count is lower than 20×10'9/L or active hemorrage happens to patients.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombocytopenia time	The lasting time for platelet count lower than 20×10'9/L after consolidation therapy.	30 days after consolidation therapy.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of thrombus	All kinds of thrombus happens in veins and arteries after consolidation therapy.	30 days after consolidation therapy.

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Guangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen University; Third Affiliated Hospital, Sun Yat-Sen University; Southern Medical University, China; Wuhan General Hospital of Guangzhou Military Command; Dongguan Kanghua Hospital
• Investigators: Principal Investigator: Dan Xu, Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Blood Platelet Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Thrombocytopenia
• Other Study ID Numbers: Eltrombopag-AML-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No