Imetelstat Sodium in Treating Patients with Primary or Secondary Myelofibrosis

Overview

About this study

This pilot clinical trial studies how well imetelstat sodium works in treating patients with primary or secondary myelofibrosis. Imetelstat sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth

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.

Study closed to enrollment

Inclusion Criteria:

  • Diagnosis of one of the following:
    • PMF per the revised World Health Organization (WHO) criteria
    • Post-ET/PV MF per the IWG-MRT criteria
  • High-risk or Intermediate-2 risk MF (as defined by the Dynamic International Prognostic Scoring System [DIPSS-plus])
  • Life expectancy of ≥ 12 weeks
  • Able to provide informed consent and be willing to sign an informed consent form
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
  • Serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
  • Total bilirubin ≤ 3.0 mg/dL (or direct bilirubin < 1 mg/dL)
  • Creatinine ≤ 3.0 mg/dL
  • Absolute neutrophil count ≥ 1000/uL
  • Platelet count ≥ 50,000/uL
  • Absence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULN
  • Females of childbearing potential must have a negative pregnancy test ≤ 7 days prior to registration, unless they are surgically sterile for at least 3 months (i.e., hysterectomy), OR postmenopausal for at least 12 months (follicle-stimulating hormone [FSH] >30 U/mL)
  • Females of childbearing potential must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study; permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed
  • Males must agree to take appropriate precautions to avoid fathering a child (with at least 99% certainty) from screening through follow-up; permitted methods for preventing pregnancy should be communicated to the subjects and their understanding confirmed

Exclusion Criteria:

  • Females who are pregnant or are currently breastfeeding
  • Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, growth factor treatment (e.g., erythropoietin) or Janus kinase (JAK) inhibitor therapy ≤ 14 days prior to registration
  • Subjects with another active malignancy
    • Note: patients with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin or cervical intraepithelial neoplasia are eligible for enrollment
  • Known positive status for human immunodeficiency virus (HIV)
  • Any unresolved toxicity greater or equal to grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
  • Incomplete recovery from any prior surgical procedures or had surgery ≤ 4 weeks prior to registration, excluding the placement of vascular access
  • Presence of acute active infection requiring antibiotics
  • Uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol

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

Ayalew Tefferi, M.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-20115559

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