NCT00290810

Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

A Phase II Trial of Bevacizumab to Prevent or Delay Disease Progression in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 this regimen in patients with relapsed or refractory CLL SECONDARY OBJECTIVES: I. Assess sensitivity to apoptosis/cell death of residual B-cell clone during therapy (e.g. is treatment selecting out a resistant clone). II. Evaluate if the risk stratification parameters (ie immunoglobulin mutational, ZAP-70, FISH defects and /or CD38 status) corresponds to both baseline apoptosis/cell death and the rates of apoptosis of CLL B-cells when cultured with Bevacizumab. III. Examine if Bevacizumab can be synergistic with other chemotherapeutic drugs such as chlorambucil or fludarabine. IV. Assess if marrow vascularity is increased at entry to study and if it is modulated following therapy with Bevacizumab. V. Examine the association of VEGF plasma levels at baseline with clinical responses to Bevacizumab. VI. Examine the levels of VCAM at entry to the study and during treatment with Bevacizumab. OUTLINE: This is a multicenter study. 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. After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

• B-cell Chronic Lymphocytic Leukemia
• Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	Given IV

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-10-01
• Completion: 2010-08-01
• First posted: 2006-02-13
• Last updated: 2014-05-09
• Results posted: 2013-05-14

Locations

1 site across 1 country: United States