Clinical Trial: Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase I Dose-Finding Study of Eltrombopag Following High Dose Cytarabine and Mitoxantrone in Relapsed/Refractory Patients With Acute Myeloid Leukemia

Brief Summary: The purpose of this study is to find out the highest safe dose and examine the side effects and effectiveness of eltrombopag olamine in patients with acute myeloid leukemia (AML) treated with chemotherapy that have not responded to previous therapy or have suffered a relapse

Detailed Summary:

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and examine the tolerability of daily oral eltrombopag (eltrombopag olamine) (14 days +/- 2 days after initiation of cytarabine) in patients receiving high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemia patients with hypoplastic bone marrow 14 days +/- 2 days from initiation of cytarabine.

II. To examine platelet count recovery to >= 100 x 10^9/L when eltrombopag is administered following high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemic patients.

OUTLINE: This is a dose-escalation study.

Patients receive eltrombopag olamine orally (PO) once daily (QD) from day 1 up to day 62. Treatment continues for up to 9 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.


Sponsor: Roswell Park Cancer Institute

Current Primary Outcome:

  • MTD and tolerability of eltrombopag olamine in patients with AML, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to day 15 ]
  • Platelet count recovery to >= 100 x 10^9/L when eltrombopag olamine is administered following high dose cytarabine and mitoxantrone for the treatment of AML patients [ Time Frame: Up to 9 weeks ]


Original Primary Outcome: MTD and tolerability of eltrombopag olamine in patients with AML [ Time Frame: First 15 days of eltrombopag olamine ]

Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.


Current Secondary Outcome:

  • Platelet recovery to >= 100 x 10^9/L and platelet response, assessed based on a modified International Working Group Consensus Criteria for hematologic improvement [ Time Frame: Up to 9 weeks ]
    Number of platelet transfusions and duration of time without platelet transfusions from the first dose of eltrombopag olamine will be measured.
  • Platelet response based on a modified International Working Group Consensus Criteria for hematologic improvement [ Time Frame: Up to 9 weeks ]
  • Platelet transfusion requirements [ Time Frame: Up to 9 weeks ]


Original Secondary Outcome: Platelet count recovery to >= 100 x 10^9/L [ Time Frame: Up to 9 weeks ]

Information By: Roswell Park Cancer Institute

Dates:
Date Received: March 7, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 4, 2016
Last Verified: April 2016