A Phase II Trial of LBH589 in Refractory Myelodysplastic Syndromes (MDS) Patients
LBH589 (20 mg PO) will be administered three times a week on Monday, Wednesday and Friday.
Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28
days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will
be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on
treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued
if there is evidence of disease progression, unacceptable toxicity and/or at the discretion
of the investigator.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (CR, Marrow CR + PR) of LBH in Patients With Relapsed or Refractory MDS.
Overall response rate (ORR) is defined by the modified International Working Group (IWG) Response Criteria for MDS. In the marrow, Complete Response (CR) is <= 5% blasts present with normal maturation of all cell lines. In peripheral blood, CR is defined as hemoglobin >= 11 g/dL, ANC >= 1000/mL, and platelets >= 100,000 with 0% blasts present. Partial Response (PR) is defined the same as CR with blasts decreased by >= 50% and >= 5% blasts in the marrow.
Ian W. Flinn, M.D.
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI MDS 07
|Florida Cancer Specialists||Fort Myers, Florida 33901|
|Northeast Georgia Medical Center||Gainesville, Georgia 30501|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|Center for Cancer and Blood Disorders||Bethesda, Maryland 20817|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|Oncology Hematology Care||Cincinnati, Ohio 45242|
|Chattanooga Oncology Hematology Associates||Chattanooga, Tennessee 37404|