NCT07281781 · University of California, Irvine
Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
What this study is about
This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.
View original scientific description
This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Significant impairment of major organ or hematopoietic function defined as
- Serum creatinine clearance less than 30 ml/min (eGFR).
- 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.
- Platelets \< 50 × 10\^9/L without transfusions
- ANC \< 0.75 × 10\^9/L without growth factors
- Known history of allergic reaction to nelfinavir.
Where
- Orange, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations