Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in AML

NCT03701217 | Unknown Phase 2

• 1 other identifier: Eltrombopag-AML-2018
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Eltrombopag; Thrombocytopenia; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The incidence of thrombus

  30 days after consolidation therapy.

Study Arms (2)

Eltrombopag treatment

EXPERIMENTAL

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 free

ACTIVE COMPARATOR

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

Interventions

Eltrombopag DRUG

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.

Eltrombopag free; Eltrombopag treatment

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia; Leukemia, Myeloid, Acute

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Dan Xu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Xu

CONTACT

+86-20-61641615; xudan2@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 9, 2018
• Study Start: September 10, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CN (1)