Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
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
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (thalidomide)
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.