Status:
COMPLETED
Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Monoclonal antibodies, such as bevacizumab, can block c...
Detailed Description
PRIMARY OBJECTIVES: I. Assess the treatment success rate of Bevacizumab in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL). II. Assess the toxicity associated with thi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00290810
Start Date
December 1 2005
End Date
August 1 2010
Last Update
May 9 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905