MyelofibrosisPhase 1/2NCT07281781
Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
A Phase 1/2 study testing Nelfinavir in people with Myelofibrosis and Myelofibrosis; Anemia, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Myelofibrosis; Anemia
- What is being tested?
- Nelfinavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to Jun 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Angela Fleischman, MD, PhD, 877-827-8839, ucstudy@uci.edu
About this study
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
- Being tested
- Nelfinavir
- Keywords
- Myelofibrosis, Anemia, Nelfinavir
- Medical subject headings
- Primary Myelofibrosis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NelfinavirDrug
Taken twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nelfinavir | Experimental | Given Orally Receives: Drug: Nelfinavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepcidin Levels
Comparison of Hepcidin Levels prior to and after Nelfinavir treatment
Measured: 30 days
Secondary outcomes (2)
Change in Hemoglobin Levels
Comparison of hemoglobin levels to determine whether there is restoration of iron to the bone marrow.
Measured: 30 days
Change From Baseline in Serum Fibrosis Biomarker Concentrations
To evaluate if nelfinavir lowers fibrosis biomarkers in serum.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start16 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela G. Fleischman, University of California, Irvine
- Investigators
- Angela Flesichman, MD, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281781
- Sponsor's protocol ID
- 6408
- Other IDs
- UCI 22-118
- Status last verified
- Apr 2026
- First submitted
- 4 Dec 2025
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No