A Phase II Trial of Thalidomide in Patients With Relapsed Chronic Lymphocytic Leukemia
I. To determine whether thalidomide can induce objective responses in relapsed B-CLL
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.
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
Confirmed response, noted as the objective status of CR, nPR, or PR on 2 consecutive evaluations at least 4 weeks apart
Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
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