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Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML

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ClinicalTrials.gov Identifier: NCT03701217
Recruitment Status : Unknown
Verified October 2018 by Dan Xu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Dan Xu, Nanfang Hospital of Southern Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eltrombopag Thrombocytopenia Acute Myeloid Leukemia Drug: Eltrombopag Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in Acute Myeloid Leukemia (AML)
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Thrombocytopenia time [ Time Frame: 30 days after consolidation therapy. ]
    The lasting time for platelet count lower than 20×10'9/L after consolidation therapy.

  2. The incidence of fatal hemorrage [ Time Frame: 30 days after consolidation therapy. ]
    Fatal hemorrage includes all bleedings have life-threaten to the patients, eg. gastrointestinal bleeding, brain bleeding, pneumorrhagia, etc.


Secondary Outcome Measures :
  1. The incidence of thrombus [ Time Frame: 30 days after consolidation therapy. ]
    All kinds of thrombus happens in veins and arteries after consolidation therapy.


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701217


Contacts
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Contact: Dan Xu +86-20-61641615 xudan2@medmail.com.cn

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Dan Xu    +86-20-61641615    xudan2@medmail.com.cn   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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
Investigators
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Principal Investigator: Dan Xu Nanfang Hospital of Southern Medical University
More Information
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Responsible Party: Dan Xu, professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03701217    
Other Study ID Numbers: Eltrombopag-AML-2018
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Thrombocytopenia
 Neoplasms by Histologic Type
Neoplasms
Blood Platelet Disorders
Hematologic Diseases