Myelofibrosis study: Nelfinavir
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?
This is an investigational medicine being studied to see if it can help with anemia and fibrosis markers in myelofibrosis. is designed to block an enzyme called HIV protease, which is part of how the drug works in the body.
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 study aims to find out if Nelfinavir can improve anemia and lower markers of scarring in the bone marrow.
- Who it's for
- People who have myelofibrosis and anemia (low red blood cell count).
- What's involved
- Participants will take Nelfinavir and have regular blood tests to check for changes in blood counts and disease markers.
- Time commitment
- The study duration and specific visit schedule are not listed in the provided text.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Orange, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.