Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

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.

Inclusion criteria

• Diagnosis of chronic lymphocytic leukemia (CLL) evidenced by monoclonal population of mature CD5+, CD19+, CD23+, and B cells
• Relapsed after prior treatment for CLL
• Active disease with 1 or more of the following characteristics:

• At least 10% weight loss within the past 6 months
• Fever greater than 100.5 degrees F for at least 2 weeks without evidence of infection
• Night sweats without evidence of infection
• Evidence of progressive marrow failure with anemia (hemoglobin less than 11 g/dL) and/or thrombocytopenia (platelet count less than 100,000/mm^3) (i.e., any stage III or IV disease)
• Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
• Massive or progressive splenomegaly (i.e., greater than 6 cm below the left costal margin or more than 50% increase over 2 months)
• Progressive lymphadenopathy (i.e., more than 50% increase over 2 months)
• Progressive lymphocytosis (not due to corticosteroids) with an increase of more than 50% over a 2-month period or an anticipated doubling time of less than 6 months
• Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not considered evidence of active disease
• Measurable disease

• Absolute lymphocyte count greater than 5,000/mm^3
• No bulky lymph node disease greater than 10 cm in at least 1 dimension except splenomegaly
• Performance status - ECOG 0-2
• Absolute neutrophil count at least 500/mm^3
• Platelet count at least 20,000/mm^3 (in absence of sargramostim [GM-CSF])
• Hemoglobin at least 8 g/dL
• Bilirubin no greater than 2.5 times upper limit of normal (ULN)
• AST no greater than 2.5 times ULN
• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• No other active malignancy
• No peripheral neuropathy (sensory) grade 2 or greater
• No active infection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 1 highly effective method of contraception AND 1 additional effective method of contraception for at least 4 weeks before, during, and for 4 weeks after study completion
• No prior allogeneic bone marrow transplantation
• At least 10 days since prior filgrastim (G-CSF) or GM-CSF
• No more than 3 prior chemotherapy regimens
• At least 30 days since prior chemotherapy
• No concurrent corticosteroids except for adrenal insufficiency