Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: B-cell Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia

In brief

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 cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer.

Key facts

Study ID

NCT00290810

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2005-12-01

Expected to finish

2010-08-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.