Refractory Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia
Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed chronic lymphocytic leukemia. Thalidomide may stop the growth of chronic lymphocytic leukemia by stopping blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To determine whether thalidomide can induce objective responses in relapsed B-CLL
patients.
II. To determine the toxicity of thalidomide in this patient population. III. To document if
alterations in vascular growth factors and/or bone marrow angiogenesis patterns correlate
with thalidomide related clinical responses.
OUTLINE:
Patients receive oral thalidomide daily for 4 weeks. Courses repeat every 4 weeks for up to
1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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