The purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML). Benefit will be based on whether or not patients can continue for 8-consecutive weeks without needing platelet transfusions, and without simultaneous worsening of hemoglobin and/or need for red blood cell (RBC) transfusion. Benefit will also be measured by hematologic response (which includes complete remission, partial remission, hematologic improvement), number of RBC transfusions, bleeding events, infections and safety.

Condition	Treatment or Intervention	Phase
Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia	Drug: Open-label lonafarnib	Phase III

Further Study Details: 

Primary Outcomes: 8-consecutive weeks of platelet transfusion independence, without worsening of red blood cell transfusion requirements or hemoglobin during the same 8-consecutive weeks
Secondary Outcomes: hematologic response rate; 4-week RBC transfusion requirements; occurrence of active bleeding; infections
Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• de novo MDS or CMML according to FAB classification (requiring at least 1 transfusion per 4-week period over an 8-week retrospective and 4-week prospective screening period).

Exclusion Criteria:

• Subjects with chemotherapy/radiotherapy-associated MDS.

Please refer to this study by ClinicalTrials.gov identifier  NCT00109538

Florida
      Bethesda Research Center, Boyton Beach,  Florida,  33435,  United States

Study ID Numbers:  P02978
Record last reviewed:  April 2005
Last Updated:  April 29, 2005
Record first received:  April 28, 2005
ClinicalTrials.gov Identifier:  NCT00109538
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03