FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Fludarabine; Cyclophosphamide; Rituximab; Bevacizumab
Intervention description: 25 mg/m^2 IV over 30 minutes daily for 3 days; 250 mg/m^2 IV over 30 minutes daily for 3 days; 375 mg/m^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m^2 IV 30-minute infusion.; 10 mg/Kg IV on Day 3, course 1 over 30-90 minutes
Intervention MeSH terms: Cyclophosphamide; Bevacizumab; Rituximab; Fludarabine; Fludarabine phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Healthy volunteers: No
Keywords: Chronic Lymphocytic Leukemia; Fludarabine; Cyclophosphamide; Rituximab; Bevacizumab; CLL

Summary:

      The goal of this clinical research study is to learn if the combination of fludarabine,
      cyclophosphamide, rituximab, and bevacizumab is effective in treating chronic lymphocytic
      leukemia in patients who have already been treated with chemotherapy. The safety of this
      treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of B-cell CLL

          -  Relapsed, fludarabine-sensitive (duration of response > 6 months as assessed by prior
             treating physician) or fludarabine-naive patients

          -  Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as
             evidenced by rapid doubling of peripheral lymphocyte count, progressive
             lymphadenopathy, progressive splenomegaly, or B symptoms.

          -  Prestudy WHO Performance Status </= 2.

          -  Signed, written Institutional Review Board (IRB)approved informed consent.

          -  Men and women of reproductive potential must agree to follow accepted birth control
             methods during treatment and for 3 months after completion of treatment.

          -  Acceptable liver function: Bilirubin </= 2.0 mg/dL (26 umol/L), AST (SGOT) and/or ALT
             (SGPT) </= 2 times upper limit of normal.

          -  Acceptable hematologic status: Platelet count >/= 50 x 10^9/L., absolute neutrophil
             count (ANC) >/= 1 x 10^9/L.

          -  Acceptable renal function: Serum creatinine </= 2.0 mg/dL

        Exclusion Criteria:

          -  Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other
             investigational therapy within 4 weeks prior to Study Day 1.

          -  Known infection with HIV, hepatitis B, or hepatitis C

          -  Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's
             Syndrome, or prolymphocyte leukemia [PLL]).

          -  Patients with secondary malignancy requiring active treatment (except hormonal
             therapy).

          -  Active uncontrolled bacterial, viral, or fungal infections.

          -  New York Heart Association Class II-IV cardiac disease or myocardial infarction within
             the past 6 months prior to Study Day 1.

          -  Pregnant or currently breast-feeding.

          -  Current, recent (within 4 weeks of the first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored
             bevacizumab cancer study.

          -  Blood pressure of > 150/100 mmHg

          -  Unstable angina

          -  History of stroke within 6 months

          -  Clinically significant peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 1, anticipation of need for major surgical procedure during the course of
             the study.

          -  Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
             prior to Day 1.

          -  Urine protein:creatinine ratio >/= 1.0 at screening.

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 1.

          -  Serious, non-healing wound, ulcer, or bone fracture.