A Phase II Trial of Bevacizumab to Prevent or Delay Disease Progression in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
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
I. Overall Survival [Time Frame: From the date of registration to the date of the event
(i.e., death or disease progression) or the date of last follow-up, up to 5 years] II. Time
to Progression [Time Frame: From the date of registration to the date of the event (i.e.,
death or disease progression) or the date of last follow-up, up to 5 years] III. Duration of
Response Defined for All Evaluable Patients Who Have Achieved an Objective Response (i.e.,
CR, nPR, PR) [Time Frame: From the date at which the patient's objective status is first
noted to be a response to the date that progression or death is documented or to the date of
last follow-up, up to 5 years]
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).
The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart. Complete Response: No lymphadenopathy No hepatomegaly or splenomegaly Absense of constitutional symptoms Polymorphonuclear leukocytes ≥ 1500/ul Platelets > 100,000/ul Hemoglobin > 11.0 gm/dl Peripheral blood lymphocytes ≤ 4000/uL. Confirmation by Marrow Aspirate and biopsy. Complete Clinical Response: -CR without bone marrow biopsy confirmation. Nodular Partial Response: -CR with the presence of residual clonal nodules. Partial Response requires: ≥ 50% decrease in peripheral blood lymphocyte count ≥ 50% reduction in lymphadenopathy ≥ 50% reduction in size of liver and/or spleen 1 or more of the following: Polymorphonuclear leukocytes ≥ 1500/ul Platelets >100,000/ul Hemoglobin >11.0 gm/dl
Up to 5 years
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|