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.