Overview

FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genentech, Inc.
Treatments:
Bevacizumab
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
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
- 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 (SGPT)
- Acceptable hematologic status: Platelet count >/= 50 x 10^9/L., absolute neutrophil
count (ANC) >/= 1 x 10^9/L.

- Acceptable renal function: Serum creatinine
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.