Phase 2
Completed N=64
FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)
Source: ClinicalTrials.gov NCT00448019 ↗Enrolled (actual)
64
Serious AEs
53.2%
Results posted
Nov 2015
Primary outcomePrimary: Progression Free Survival (PFS) Rate — 13.5 Months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Rate |
13.5 | — |
| SECONDARY Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL) |
13; 24; 8 | — |
| SECONDARY Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL |
79 | — |
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 /= 50 x 10^9/L., absolute neutrophil count (ANC) >/= 1 x 10^9/L.
- Acceptable renal function: Serum creatinine 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.
Data sourced from ClinicalTrials.gov (NCT00448019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.