Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01113502
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01113502
Study Brief:
Protocol Section:
NCT01113502