Recruiting
Phase 1
Phase 2

Nelfinavir

Sponsor:

UCLA

Code:

NCT07281781

Conditions

Myelofibrosis

Myelofibrosis; Anemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nelfinavir

Study Details

Brief summary:

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

Conditions

Myelofibrosis

Myelofibrosis; Anemia

Study ID

NCT07281781

Start date

Sep 16, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nelfinavir

Given Orally

Interventions

Nelfinavir

Taken twice daily

Primary outcome measure

  • Change in Hepcidin Levels [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Angela Fleischman, MD, PhD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Myelofibrosis
  • Anemia
  • Nelfinavir

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-05-04.