Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms
Reason given: PI discretion
Key facts
- Where
- Cleveland, United StatesSee the site
- Phase
- Phase 1/2
Where in United States
- Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, United StatesNo longer taking part
Trial details
- Who runs it
- Case Comprehensive Cancer Center
- Trial code
- NCT04629651
- Record updated
- 11 October 2023
- Original description
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.Read full original descriptionShow less
Phase I/II Prospective Trial Investigating the Safety and Efficacy of Captopril Use on the Degree of Marrow Fibrosis in Patients With Primary or Secondary Bone Marrow Fibrosis/Myeloproliferative Neoplasms
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.
Inclusion: 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study-related procedure is done that is not part of standard medical care, with the understanding that consent may be withdrawn by the participants any time without prejudice to future medical care.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: Completed hematopoietic cell transplant (HCT); 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; Participants receiving any other investigational agents; Known allergy/hypersensitivity to ACE inhibitors; Participants with creatinine clearance <30 ml/minute or on dialysis; Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent; 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; Pregnant or nursing participants - captopril is a risk category D and is excreted in breast milk.