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:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT04878003
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
* High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
* ECOG of 0 or 1
Exclusion Criteria:
* Subjects who are positive for p53 mutation (Arm 1)
* Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
* Prior treatment with any JAK inhibitor
* Prior splenectomy
* Splenic irradiation within 24 weeks prior to randomization
* Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
* History of major organ transplant
* Grade 2 or higher QTc prolongation
* Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04878003
Study Brief:
Protocol Section:
NCT04878003