Clinical Trials

4 studies in Chronic Myelomonocytic Leukemia

1. Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia Scottsdale and Phoenix, AZ Rochester, MN View Summary
   Close

   Azacitidine With or Without Lenalidomide or Vorinostat in Patients With Higher-Risk Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To test whether the response rate (complete remission, partial remission, or hematologic improvement) of patients with higher-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who receive either the combination of lenalidomide and azacitidine or the combination of vorinostat and azacitidine is improved compared to patients who receive single-agent azacitidine. II. To estimate relapse-free survival, overall survival and cytogenetic response rate of patients treated on each regimen. III. To estimate the frequency and severity of toxicities of the three regimens in this patient population. IV. To investigate in a preliminary manner the frequency of subgroups from pre-study cytogenetic studies and correlate these subgroups with clinical outcomes in this patient population. V. To collect specimens for banking for use in future research studies. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 or days 1-5 and 8-9, and lenalidomide orally (PO) once daily (QD) on days 1-21. ARM II: Patients receive azacitidine as in arm I. ARM III: Patients receive azacitidine as in arm I and vorinostat PO twice daily (BID) on days 3-9. In all arms, courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 5 years.

   NCT ID:

   NCT01522976

   IRB Number:

   12-003338

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Mrinal M. Patnaik 507-538-7623
                       
   Scottsdale: Mrinal M. Patnaik 507-538-7623
                       
   
   

   Request Information Online
2. Safety Study of Anti-Programmed Death-1 in Hematologic Malignancy Rochester, MN View Summary
   Close

   Safety Study of Anti-Programmed Death-1 in Hematologic Malignancy

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to determine the side effects of treatment with the monoclonal antibody anti-PD-1 (BMS-936558) in subjects with relapsed/refractory hematologic malignancy and the dose that should be recommended for use in future studies.

   NCT ID:

   NCT01592370

   IRB Number:

   12-004166

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Stephen Ansell, Site 002 507-284-0923
                       
   
   
   

   Request Information Online
3. Phase IIb Study of Dasatinib Versus Imatinib in Patients With CML-CP Who Have Not Achieved an Early Optimal Response to Imatinib Rochester, MN View Summary
   Close

   Phase IIb Study of Dasatinib Versus Imatinib in Patients With CML-CP Who Have Not Achieved an Early Optimal Response to Imatinib

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The study purpose is to test the hypothesis that patients with Chronic phase-Chronic Myeloid Leukemia (CP-CML) with BCR-ABL transcript level > 10% International Standard (IS) after 3 months of treatment with first line Imatinib 400mg will achieve a greater rate of major molecular response (MMR) by early switching to Dasatinib therapy 100mg once daily (QD) compared with continued treatment with Imatinib at any dose.

   NCT ID:

   NCT01593254

   IRB Number:

   12-006064

   • Print Summary
   • View study details
4. Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC) Rochester, MN View Summary
   Close

   Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib. Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis (low, intermediate, high), to receive once daily oral administration of either ponatinib or imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates at various timepoints; time to, duration of, and durability of responses; and survival follow-up. Safety measures include clinical laboratory testing, adverse event monitoring, vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status, and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is expected to take approximately 2 years, and patients will be followed for survival for up to 8 years after the last patient's first dose; therefore, patient participation may last up to 10 years.

   NCT ID:

   NCT01650805

   IRB Number:

   12-006195

   • Print Summary
   • View study details

   Who can I contact for additional information about this study?

   Rochester: Doug Waldner
                       
   
   
   

   Request Information Online