Clinical Trials

Imetelstat Sodium in Treating Patients With Primary or Secondary Myelofibrosis

Location:

Rochester, MN

Trial status:

Open for Enrollment

Why is this study being done?

PRIMARY OBJECTIVES: I. To evaluate overall response rate. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of imetelstat (imetelstat sodium) in myelofibrosis (MF) (per common terminology criteria for adverse events, version 4.03). II. To evaluate the efficacy of imetelstat in the reduction of spleen size, as measured by physical examination (palpable distance from the left costal margin). III. To evaluate the efficacy of imetelstat in inducing red blood cell transfusion-independence in previously transfusion-dependent patients (per International Working Group for Myelofibrosis Research and Treatment [IWG-MRT] criteria). TERTIARY OBJECTIVES: I. To evaluate the effect of imetelstat on bone marrow histology and karyotype. II. To evaluate the effect of imetelstat on leukocytosis and thrombocytosis. OUTLINE: Patients receive imetelstat sodium intravenously (IV) over 2 hours on day 1. Treatment repeats every 21 days for up to 52 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years.

Last updated: 11/18/2012

NCT ID:

NCT01731951