A study to evaluate the test drug (Imetelstat) in blood transfusion dependent patients with Low or Intermediate Risk Myelodysplastic Syndrome.

What we are studying

You have been asked to take part in this study because you have been diagnosed with myelodysplastic syndrome. Myelodysplastic syndrome is a type of cancer that affects how blood cells are made. This study has 2 separate parts. About 200 patients in total will participate in this worldwide study: about 30 patients in Part 1 and about 170 patients in Part 2. All patients participating in Part 1 of this study will get 7.5 mg/kg of imetelstat as a 2-hour intravenous infusion once every 4 weeks. Not everyone in Part 2 of the study will get imetelstat. There are two treatment groups in this study: • Patients in Treatment Group A will receive 7.5 mg/kg of imetelstat given in a vein for 2 hours once every 4 weeks. Before receiving imetelstat, you will receive 25-50mg of diphenhydramine (an antihistamine) and 100-200 mg of hydrocortisone (a corticosteroid), or equivalent. • Patients in Treatment Group B will receive placebo given in your vein for 2 hours once every 4 weeks. Before receiving placebo, you will receive 25-50mg of diphenhydramine (an antihistamine) and 100-200 mg of hydrocortisone (a corticosteroid), or equivalent. The amount of time you will be in the study may vary. This is because you will remain in the study and continue to take the study drug for as long as it is helping you. The study will last approximately 2 years after the last patient has been enrolled into the study

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

  • Adequate iron stores
  • Non-Pregnant women
  • Cannot have allergies
  • Hypersensitivity
  • Or intolerance to imetelstat
  • No major surgery within 4 weeks prior to study entry
  • HIV negative
  • No past or present active hepatitis infection of any type
  • No clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias
  • Congestive heart failure
  • Or myocardial infarction within 6 months of study entry
  • No past or present active hepatitis infection of any type

What is involved

  • Physical exam
  • ECG
  • Bone marrow biopsy and aspirate
  • Pregnancy test
  • Blood draw
  • Questionnaires

Compensation

Patients will be reimbursed for travel expenses, parking and meals.

Contact Information

Study Coordinator
Scarlett Hutchens
Email
snhutche@wakehealth.edu
Phone
336-713-6915
Principal Investigator
Dr. Bayard Powell

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.