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Purpose

This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ≥18 years of age - Have a diagnosis of myelofibrosis (MF) according to the 2016 WHO criteria - Has a hemoglobin ≤ 10gm/dL at screening - Serum ferritin ≥ 100 - May continue on current MPN treatment, including aspirin, hydroxyurea, interferon-alpha, ruxolitinib, fedratinib, or anagrelide. - Peripheral blast count <10% during Screening. - Free of other known active or metastatic malignancies other than localized skin cancer. - Amenable to blood draws and symptom assessments. - Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.

Exclusion Criteria

  • Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3 - Currently pregnant or planning on being pregnant within the study period. - Currently taking Momelotinib or Pacritinib (these agents are purported to reduce hepcidin). - Currently taking any of the contraindicated medications to Nelfinavir listed in section 13.2 - Currently breastfeeding. - Known uncontrolled active viral or bacterial infection. - Known HIV+ - Significant impairment of major organ or hematopoietic function defined as 1. Serum creatinine clearance less than 30 ml/min (eGFR). 2. Bilirubin more than 1.5 mg/dl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis. 3. Platelets < 50 × 10^9/L without transfusions 4. ANC < 0.75 × 10^9/L without growth factors - Known history of allergic reaction to nelfinavir.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nelfinavir 		Given Orally
  • Drug: Nelfinavir
    Taken twice daily

Recruiting Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange 5379513, California 5332921 92868
Contact:
Angela Fleischman, MD, PhD
877-827-8839
ucstudy@uci.edu

More Details

Status
Recruiting
Sponsor
University of California, Irvine

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine
1-877-827-8839
ucstudy@uci.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.