Eltrombopag in Elderly Acute Myelogenous Leukemia (AML)

• Status: Terminated
• Trial end date: 2015-11-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I/II open label study being conducted to evaluate the overall safety and initial effectiveness of an investigational drug, Eltrombopag in patients who are 60 years of age and older and who have Acute Myelogenous Leukemia (AML). Eltrombopag is an investigational drug, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for use in this type of disease. Approximately 35 people will be enrolled on this study at the University of Pennsylvania

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania

Criteria

Inclusion Criteria:

• A diagnosis of non-M3 AML which is either: a). Relapsed after standard chemotherapy or transplant;

• Newly diagnosed in a patient who is not an appropriate or willing candidate for standard induction chemotherapy - Age equal to or greater than 60 - Platelet count less than 75 - ECOG performance status of 0-2

• Life expectancy of at least 4 weeks

• Must be able to consume oral medication

• Must have recovered from toxic effects of prior chemotherapy

• Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.

• For Phase I portion only: Subject must be of non-East Asian (Japanese, Chinese, Taiwanese or Korean) descent.

• For Phase II portion subject can be either East Asian or non-East Asian descent.

Exclusion Criteria:

• Cytotoxic chemotherapy (including azacitidine or decitabine) within the past 28 days other than hydroxyurea

• Active participation in any other investigational treatment study for AML.

• Known HIV or Hepatitis C

• ECOG performance status greater than 2

• Uncontrolled intercurrent illness including, but not limited to: uncontrolled ongoing infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Previous therapy with romiplostim or any other TPO-R agonist