A study to test intravenous PRM-151 for safety and to see how different doses of PRM-151 act in the body and blood of people with myelofibrosis - a disorder of the bone marrow, in which the marrow is replaced by scar (fibrous) tissue.

What we are studying

The purpose of this study is to gather information on whether PRM-151 has an effect on your MF disease, whether it is safe in patients with MF, and how well it is tolerated (that is, whether or not it makes you feel ill. Approximately 84 subjects with MF will take part in this study in study centers in the United States, Canada and Europe. Each subject will participate in the study for approximately 44 weeks. These 44 weeks include: the screening period, which will begin approximately 28 days before the first PRM-151dose is given; a study period (when you receive the PRM-151 infusions) of 36 weeks and a follow up period (after you are done with PRM-151 infusions). During the 36 week study period, you will have up to 11 outpatient visits. During the follow-up period, one visit approximately 29 days after your last infusion and one more at about 28 days after your last visit, or approximately 60 days after your last infusion of the study drug, for a total of 2 visits during the follow-up period.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Diagnosis with myelofibrosis
  • Cannot be a candidate for ruxolitinib therapy
  • Life expectancy at least 12 months
  • Not pregnant
  • Ability to adhere to study visit schedule
  • Adequate organ function
  • No other cancers within last 3 years (except non-melanoma skin-cancer and cured prostate and cervical cancer)
  • No active serious infections

What is involved

  • Screening visit
  • 11 outpatient visits during study treatment period
  • 29 day follow-up visit after last infusion and one more at 28 days after last visit. During treatment period
  • You will receive PRM-151 on days 1
  • 3 and 5 of the first week and subsequently on day 1 every 4 weeks for up to 36 weeks; Quality of Life Questionnaires
  • Blood work
  • ECG
  • Bone marrow biopsy
  • PET/CT

Compensation

none, however the Comprehensive Cancer Center of Wake Forest University will provide you with a parking voucher for your study related visits.

Contact Information

Study Coordinator
Suzanne Carroll
Email
scarroll@WakeHealth.edu
Phone
(336)713-5719
Principal Investigator
Dmitriy Berenzon, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.