Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms (NCT04629651) | Clinical Trial Compass
WithdrawnPhase 1/2
Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms
Stopped: PI discretion
United States0Started 2024-04
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of captopril and evaluate the effectiveness captopril as measured by changes in the grade of bone marrow scar tissue. The change in spleen size by ultrasound will also be measured.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically confirmed diagnosis of primary myelofibrosis (PMF), or post-polycythemia vera/essential thrombocythemia-MF (i.e. secondary MF) by 2016 WHO criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 -2
* Creatinine clearance \>30 ml/minute
* Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment. All men and women of childbearing potential must use acceptable methods of birth control throughout the study.
* Participants should be able to give voluntary informed written consent to participate in the study. Informed consent will be obtained prior to enrollment and before any study-related procedure is done that is not part of standard medical care, with the understanding that consent may be withdrawn by the participants any time without prejudice to future medical care.
Exclusion Criteria:
* Completed hematopoietic cell transplant (HCT)
* Presence of \>10% blasts in peripheral blood or on bone marrow examination
* Screening blood pressure(BP)parameters of systolic BP \< 100 and diastolic BP \< 60
* Splenic irradiation within 3 months prior to the first dose of captopril
* Prior ACE inhibitor, angiotensin II receptor antagonist, or aliskiren use within 12 months prior to trial enrolment
* Known allergy/hypersensitivity to ACE inhibitors
* Participants receiving any other investigational agents
* Pregnant or nursing participants - captopril is a risk catego…
What they're measuring
1
Change in degree of bone marrow fibrosis by World Health Organization WHO grade