A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Sponsor: |
Geron Corporation |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ4700 |
U.S. Govt. ID: |
NCT02598661 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of the study is to evaluate the efficacy and safety of imetelstat for the treatment of patients with myelodysplastic syndrome (MDS). 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. The dose of imetelstat may be increased, held or decreased depending on how well imetelstat works to treat your MDS and whether or not you have certain side effects to treatment. Before receiving imetelstat, you will receive 25-50mg of diphenhydramine (an antihistamine) and 100-200 mg of hydrocortisone (a corticosteroid), or equivalent.
This study is closed
Investigator
Azra Raza, MD
Are you age 18 years or older? |
Yes |
No |
Have you been diagnosed with myelodysplastic syndrome? |
Yes |
No |