HOPE-PMF: Pre-fibrotic/Early Primary Myelofibrosis or Overt Primary Myelofibrosis - Clinical Trial
¿Cuál es el Propósito de este estudio?
We are doing this study to find the most effective, safe dose of an experimental drug called P1101 (the study drug) in adults with early or low risk primary myelofibrosis (PMF).
Pre-fibrotic/Early Primary Myelofibrosis or Overt Primary Myelofibrosis at Low or Intermediate-1 Risk
¿Quién puede participar en el Estudio?
Adults ages 18+ who:
- Are diagnosed with pre-fibrotic/early PMF or overt PMF at low or intermediate-1 risk according to DIPSS plus risk calculator
- Have good liver function
- Have a hemoglobin level of 10.0 g/dL at start of study
- Do not have any hypersensitivity or contraindication to interferon
- Are not eligible for JAK inhibitor therapy
For more information, contact the study team at erin.murphy@duke.edu.
¿Qué Implica?
If you are able to take part in this research study, you will be randomly assigned to receive P1101 or a placebo (a liquid without the medication).
Screening Visit (visit window: -28 days to -1 day) - tests to determine your eligibility to participate.
Baseline Visit (Week 0)
Dose Escalation Period (Week 2 to Week 4 visits)
Study medication injection during the Core Study Drug Period: During the Baseline Visit and Dose Escalation Period, you will receive P1101 (study group) or placebo (placebo group) during your clinic visit on the following schedule: Baseline visit (Day 0) = 250 mcg; Week 2 = 350 mcg; Week 4 = 500mcg
Core Study Drug Period (Week 8 to Week 76 visits) - visits will occur roughly every 4 weeks during the 76-week Core Study Drug Period
End of Core Study Drug Visit (Week 80 of receiving P1101/placebo)
Safety Follow-up Visit for the Core Study Phase (~28 days after the last dose of P1101/placebo) - If you participate in the Blinded Extension Phase, the Safety Follow-up Visit will also serve as the Screening Visit for the Blinded Extension Phase.
On-site biweekly study procedures for visits for whom self-injection is not possible (every 2 weeks)
Early Termination Visit
During the study visits the following tests may be done physical examinations, echocardiogram, eye exam, vitals, blood and urine samples collected, electrocardiogram (ECG), chest x-ray, questionnaires, spleen measurements, and bone marrow samples.
You are expected to be in this research study for roughly 2.5 years (80 weeks for the Core Study Phase, 4 weeks of Safety Follow-up Visit, and 60 weeks for the Blinded Extension Phase [separate consent form]) or longer, depending on disease progression. If you are found to be positive for drug antibodies at your safety follow-up (end of study), we will need to check again in 12 weeks and 24 weeks or until you test negative, whichever comes first.
Detalles del Estudio
