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New treatment option for Myelofibrosis
Official title Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow
ClinicalTrials.gov ID: NCT07281781
What this study is testing
What is Nelfinavir?
Nelfinavir is an investigational medicine, given as an once-daily, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I/II protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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.
You likely can't join if
- 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.
See the full eligibility 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 people of childbearing potential and their male partners, or male people who have female partners of childbearing potential, should both use an effective contraception method...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.