Clinical trial · Interventional
FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)
Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia
NCT00448019CI-TRIAL-00019664completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FCR + Bevacizumab
- description
- FCR = Fludarabine 25 mg/m\^2 intravenous (IV) , Cyclophosphamide 250 mg/m\^2 IV daily for 3 days, Rituximab 375 mg/m\^2 IV Day 1, followed by 500 mg/m\^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
- interventionNames
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Rituximab
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Rate
- timeFrame
- Baseline up to 5 years
- description
- Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- RESULTJain P, Lee HJ, Qiao W, Wierda W, Benjamini O, Burger J, Ferrajoli A, Estrov Z, Kantarjian H, Keating M, O'Brien S. FCR and bevacizumab treatment in patients with relapsed chronic lymphocytic leukemia. Cancer. 2014 Nov 15;120(22):3494-501. doi: 10.1002/cncr.28910. Epub 2014 Jul 15. PMID 25043749