RecruitingPhase 1Phase 2NCT07281781

Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow

Sponsor

University of California, Irvine

Enrollment

10 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Myelofibrosis Myelofibrosis; Anemia

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria9

≥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 Criteria13

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
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.

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Interventions

DRUGNelfinavir

Taken twice daily

Locations(1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

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NCT07281781

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