A Study of Aplidin for Treating Patients with Primary Myelofibrosis, Post Polycythemia Vera or Essential Thrombocythemia Myelofibrosis

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of Aplidin® (plitidepsin) for the treatment of Patients who have primary myelofibrosis and post polycythemia vera/essential thrombocythemia myelofibrosis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Diagnosis of Primary Myelofibrosis (PMF) or Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis(post-ET/PV MF) as per revised World Health Organization (WHO) criteria
  • High-risk or intermediate-2 risk Myelofibrosis (MF) as defined by the International Prognostic Scoring System (IPSS)
  • Intermediate-I risk MF associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to available therapy
  • Age at least 18 years 
  • Life expectancy of ≥12 weeks
  • Able to provide informed consent and willing to sign an informed consent form (ICF)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Evidence of acceptable organ function within seven days of initiating study drug

Exclusion Criteria

  • Previous treatment with plitidepsin
  • Any of the following therapies within two weeks prior to initiation of study drug
    • Chemotherapy (e.g., hydroxyurea)
    • Immunomodulatory drug therapy (e.g., thalidomide)
    • Immunosuppressive therapy
    • Corticosteroids >10 mg/day prednisone or equivalent
    • Erythropoietin
  • Incomplete recovery from major surgery within four weeks of study entry
  • Radiation therapy within four weeks of study entry
  • Women of childbearing potential
  • Women who are pregnant or are currently breastfeeding
  • Myopathy grade > 2
  • Known positive status for human immunodeficiency virus (HIV)
  • Active hepatitis B or C virus (HBV or HCV) infection
  • Diagnosis of another invasive malignancy
  • Any acute active infection
  • Known hypersensitivity to the study drug or any of its formulation components (e.g., Cremophor®)
  • Treatment with any investigational product in the 30 days before inclusion in the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Animesh Pardanani, M.B.B.S., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314834

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