Phase II Multicenter Study of Amifostine in Patients With Myelodysplastic Syndromes at Relatively Low Risk of Developing Acute Leukemia
OBJECTIVES: I. Compare the effect of amifostine alone and in combination with epoetin alfa
on bone marrow progenitor cells and number of blast cells, blood leukocyte counts,
reticulocytes, hemoglobin level, and platelet counts as well as peripheral blood and bone
marrow blast cell count in patients with myelodysplastic syndromes at a low risk of
developing acute leukemia. II. Determine partial or complete response and duration of
response in this patient population. III. Characterize the subjective and objective toxicity
of amifostine in these patients.
OUTLINE: This is a multicenter study. Patients receive amifostine IV 3 times per week for 3
weeks followed by 1 week of rest. Response is assessed after 2 courses of therapy. Treatment
continues in the absence of disease progression. Patients with complete response receive 1
additional course. Patients with partial response or stable disease are stratified into 2
groups: Group 1: Patients with hemoglobin of at least 10 g/dL without transfusion receive 2
additional courses of amifostine alone. Group 2: Patients with hemoglobin less than 10 g/dL,
or who are transfusion dependent, receive 2 additional courses of amifostine in combination
with epoetin alfa subcutaneously 3 times per week. Both groups are reevaluated after these 2
additional courses. Treatment may then continue at the discretion of the treating physician.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 27-50 patients will be accrued to this study within 1.3 years.
Primary Purpose: Treatment
Roel Willemze, MD, PhD
Leiden University Medical Center
United States: Federal Government