Clinical Trials

5 studies in myelofibrosis

1. Multiple Ascending Dose of BMS-911543 Rochester, MN View Summary
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   Multiple Ascending Dose of BMS-911543

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.

   NCT ID:

   NCT01236352

   IRB Number:

   11-000950

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   Who can I contact for additional information about this study?

   Rochester: Animesh D. Pardanani, Site 004
                       
   
   
   

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2. Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF Scottsdale and Phoenix, AZ View Summary
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   Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)

   NCT ID:

   NCT01423851

   IRB Number:

   11-000895

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   Who can I contact for additional information about this study?

   
   Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   

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3. Imetelstat Sodium in Treating Patients With Primary or Secondary Myelofibrosis Rochester, MN View Summary
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   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.

   NCT ID:

   NCT01731951

   IRB Number:

   12-005104

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   Who can I contact for additional information about this study?

   Rochester: Mayo Clinic Clinical Trials Referral Office 507-538-7623
                       
   
   
   

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4. Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis Scottsdale and Phoenix, AZ View Summary
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   Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To evaluate the efficacy (best overall response) of ruxolitinib (ruxolitinib phosphate) and danazol in patients with myelofibrosis suffering from anemia. SECONDARY OBJECTIVES: I. To evaluate the overall survival of patients with myelofibrosis suffering from anemia initiating ruxolitinib and danazol. II. To evaluate the adverse event profile of ruxolitinib and danazol in patients with myelofibrosis suffering from anemia. TERTIARY OBJECTIVES: I. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) with ruxolitinib and danazol for patients with myelofibrosis suffering from anemia. OUTLINE: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) and danazol PO thrice daily (TID) on days 1-56. Treatment repeats every 56 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

   NCT ID:

   NCT01732445

   IRB Number:

   12-002466

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   Who can I contact for additional information about this study?

   
   Scottsdale: Mayo Clinic Clinical Trials Referral Office 507-538-7623
                       
   
   

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5. Correlative Biomarker Study in Patients With Myeloproliferative Disorders Scottsdale and Phoenix, AZ View Summary
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   Correlative Biomarker Study in Patients With Myeloproliferative Disorders

   Location:

   Scottsdale and Phoenix, AZ

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Researchers will use abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma, in laboratory studies. Toenail clippings will provide normal material like DNA for comparison with the abnormal material derived from the blood and/or bone marrow. The results of these studies will be correlated with subjects' disease symptoms and response to their experimental treatment. The MPD-RC researchers are interested in studying molecules from the blood and bone marrow, the exact molecules changing over time with the investigators choosing only the most promising for investigation. The investigators are attempting to better understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases. These syndromes carry a high risk of developing leukemia. It is important to continue to learn more about these blood cancers and to learn more about the effectiveness and potential side effects of various treatments. It is believed that further basic knowledge about these cancer cells as well as the effects of treatment will lead to the improvement of current therapies and the development of entirely new treatments for these diseases. The MPD-RC is hoping to determine if a number of laboratory tests (biomarkers) will allow for the prediction of response in future patients to the treatment they would receive.

   NCT ID:

   NCT00665067

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   Who can I contact for additional information about this study?

   
   Scottsdale: Ruben Mesa, MD 480-301-8335
                       
   
   

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