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
- Are there results?
- Not yet: the study is under way
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.
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- 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.
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- 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 2027 (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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Oct 2026
- First submitted
- 4 Dec 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
- ClinicalTrials.gov ID
- NCT07281781
- Acronym / sponsor ID
- 6408
- Conditions
- Myelofibrosis, Myelofibrosis; Anemia
- Keywords
- Myelofibrosis, Anemia, Nelfinavir
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelfinavir | Experimental | Drug: NelfinavirGiven Orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NelfinavirTaken twice daily | Drug | Nelfinavir |
Primary outcome
Change in Hepcidin Levels
Time frame: 30 days
Comparison of Hepcidin Levels prior to and after Nelfinavir treatment
2 secondary outcomes
Change in Hemoglobin Levels
Time frame: 30 days
Change From Baseline in Serum Fibrosis Biomarker Concentrations
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Related trials for Myelofibrosis
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A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
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Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Angela Flesichman, MD, PhD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepcidin Levels (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.