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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Given PO
Correlative studies
North Central Cancer Treatment Group
Rochester, Minnesota, United States
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.
Time frame: Up to 5 years
Overall survival
The Kaplan-Meier method will be used.
Time frame: Up to 5 years
Progression-free survival
The Kaplan-Meier method will be used.
Time frame: Up to 5 years
Time to progression
The Kaplan-Meier method will be used.
Time frame: Up to 5 years
Duration of response
Time frame: Up to 5 years
Maximum grade of each type of toxicity
Frequency tables will be reviewed.
Time frame: Up to 5 years
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