Recruiting NCT07281781

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

Phase I / Phase II Interventional Myelofibrosis Myelofibrosis; Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nelfinavir.
Who it may be relevant to: Registry conditions: Myelofibrosis, Myelofibrosis; Anemia. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Secondary outcome measures (2)

Change in Hemoglobin Levels [Time frame: 30 days]
Change From Baseline in Serum Fibrosis Biomarker Concentrations [Time frame: 30 days]

≥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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange

NCT: NCT07281781 · 6408 · UCI 22-118