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PRM-151G-101:  A Phase 2, Prospective Study of PRM-151 in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), Or Post-Essential Thrombocythemia MF (post-ET MF)

Eligibility Criteria:
The following information is provided as a guide to investigators.  Inclusion and exclusion criteria can be complex and requires the study physician to review each potential subject's eligibility individually. To learn if you are eligible for this study, it is important that you contact the study research staff at a study site. 

Find an open study site here.

Inclusion Criteria


  •  Must be >18 years of age at the time of signing the informed consent.
  • Must have pathologically confirmed diagnosis of PMF per WHO diagnostic criteria or post ET/PV MF.
  • At least Grade 2 bone marrow fibrosis according to WHO Grading.
  • Intermediate-1, intermediate-2 or high risk disease according to the IWG-MRT Dynamic International Prognostic Scoring System
  • Bone marrow biopsy performed within 4 weeks prior to cycle 1 day 1 treatment.
  • Not be candidates for ruxolitnib based on EITHER:
    • Platelet count <50x109/L
    • Hgb <100g/L, have received > 2 units of PRBC in the 12 weeks prior to study entry and be intolerant of or had inadequate response to ruxolitinib.
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy as judged by the investigator of at least 12 months.
  • At least 4 weeks since the last dose of MF directed drug treatment (including investigational therapies) before enrollment into the study.
  • Recovery to <  Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia.
  • Women of child bearing potential must have negative serum pregnancy test and agree to utilize adequate methods of contraception as outlined in the protocol.
  • Ability to adhere to the study visit schedule and protocol requirements.
  • Must have adequate organ function as demonstrated by:
    • ALT (SGPT) and/or AST (SGOT) ≤ 3x upper limit of normal (ULN), or ≤ 4 x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF)
    • Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF)
    • Serum creatinine ≤ 2.5 mg/dL x ULN.

 

Exclusion Criteria:


  • White blood cell count > 25 x 10e9/L or > 10% peripheral blood blasts.
  • Other invasive malignancies within the last 3 years, except non- melanoma skin cancer and localized cured prostate and cervical cancer.
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months;
  • Presence of active serious infection.
  • Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection.
  • Organ transplant recipients other than bone marrow transplant.
  • Women who are pregnant or lactating.