A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase
I. Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in
patients with blastic phase chronic myelogenous leukemia.
II. Determine the toxicity profile of this regimen in these patients. III. Determine the
effect of bevacizumab on angiogenesis in these patients.
Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive
bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine
subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a
maximum of 3 courses. Patients with responding disease receive maintenance therapy
comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and
cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in
the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement in response rate
Up to 3 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M D Anderson Cancer Center||Houston, Texas 77030|