Captopril Use on the Degree of Marrow Fibrosis in Bone Marrow Fibrosis/Myeloproliferative Neoplasms
Bone Marrow Fibrosis, Myeloproliferative Neoplasm
About this trial
This is an interventional treatment trial for Bone Marrow Fibrosis focused on measuring primary myelofibrosis (PMF), post-polycythemia vera/essential thrombocythemia-MF (secondary MF)
Eligibility Criteria
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study-related procedure is done that is not part of standard medical care, with the understanding that consent may be withdrawn by the participants any time without prejudice to future medical care.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 category D and is excreted in breast milk
- 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
Sites / Locations
- Cleveland Clinic, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Captopril
In phase I, Cohorts of 3 patients each will receive doses of captopril with a goal dose of 150mg total by mouth (PO) daily. Initial dose per patient will start at 12.5 mg daily, which will then be increased on weekly intervals as tolerated. To be administered per the intra-patient dose escalation scheme below Phase I: Day 0: 12.5mg/day Day 7: 12.5mg twice daily Day 14: 12.5mg three times daily Day 21: 25mg three times daily Day 28: 50mg three times daily Phase II: The efficacy of captopril will be assessed in the Phase II portion. Captopril given at Maximum Tolerated Dose - bone marrow evaluation to be done at 6 months