Bevacizumab in Treating Patients With Relapsed or Refractory 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 B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following phenotypic characteristics: Predominant population of cells share both B-cell antigens (CD19, CD20, or CD23) as well as the T-cell antigen (CD-5), in the absence of other pan-T-cell markers (CD-3, CD-2, etc.) Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11;14) by fluorescent in situ hybridization (FISH) Dim surface immunoglobulin expression Exclusively kappa and lambda light chains Peripheral blood absolute lymphocyte count > 5,000/mm^3 Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically Requires chemotherapy, as indicated by any of the following: Disease related symptoms, including the following: Weight loss ≥ 10% within the previous 6 months Extreme fatigue Fevers > 100.5°F for 2 weeks without evidence of infection Night sweats without evidence of infection Evidence of progressive marrow failure, as manifested by the development of or worsening anemia (hemoglobin ≤ 10 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm^3) Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly Measurable and progressive lymphadenopathy Measurable (i.e., > 5,000/mm^3) and progressive lymphocytosis Progressive disease or relapsed after or refractory to 1 course of an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen No marrow function attributable to dysplasia related to prior therapy ECOG performance status 0, 1, or 2 Serum creatinine < 2 mg/dL If serum creatinine > 1.5 mg/dL but < 2 mg/dL, creatinine clearance must be ≥ 30 mL/min Platelet count > 30,000/mm^3 Direct bilirubin ≤ 2 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other second malignancy within the past 2 years except squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix No New York Heart Association class III or IV heart failure No blood pressure > 150/90 mm Hg No unstable angina No myocardial infarction or stroke within the past 6 months No clinically significant peripheral vascular disease No evidence of bleeding diathesis or coagulopathy No significant traumatic injury within the past 28 days Urine protein:creatinine (UPC) ratio ≤ 1.0 Patients with a UPC ratio > 1.0 must undergo a 23-hour urine collection and must demonstrate < 1 gram of protein per day No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months No serious, non-healing wound, ulcer, or bone fracture No active infections requiring oral or intravenous antibiotics No active bleeding or pathological conditions that carry a high risk of bleeding (e.g., known varices) No thrombocytopenia requiring transfusion See Disease Characteristics More than 4 weeks since prior participation in an experimental drug study At least 8 weeks since prior rituximab At least 6 weeks since prior chemotherapy More than 28 days since prior major surgery or open biopsy More than 7 days since prior minor surgery, fine needle aspirations, or core biopsies No concurrent major surgery No concurrent participation in another experimental drug study Concurrent full-dose warfarin or low molecular weight heparin allowed provided patient is on a stable dose AND INR is in range
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (monoclonal antibody therapy)
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.