NCT07281781 Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
| NCT ID | NCT07281781 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-09-16 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.
Eligibility Criteria
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.
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 1-877-827-8839
Angela Flesichman, MD, PhD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07281781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07281781 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07281781 currently recruiting?
Yes, NCT07281781 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT07281781 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT07281781 clinical trial?
NCT07281781 is sponsored by University of California, Irvine. The principal investigator is Angela Flesichman, MD, PhD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 10 participants.