Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia
N/A
N/A
Both
Chronic Lymphocytic Leukemia
Trial Information
Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia
During the study, you will have up to 6 "cycles" of treatment. A cycle is made up of
treatment with the study drugs for 3-4 days and then about 3-1/2 weeks (25 days) of no
treatment (about 4 weeks total). Treatment with the study drugs will be given for 4 days in
a row on the first cycle, and 3 days in a row on Cycles 2-6. On Day 1 of each cycle, you
will receive rituximab through a needle in a vein. On Cycle 1, since it is your first
exposure to rituximab, it must be given slowly, so it may take 6-8 hours to complete. On
the cycles after that, it can be given more rapidly, over 3-4 hours. Cyclophosphamide and
fludarabine will be given separately through a needle in a vein on Days 2-4 of Cycle 1 and
Days 1-3 of Cycles 2-6. Cyclophosphamide and fludarabine will each be given over 30
minutes. Bevacizumab will be given through a needle in a vein over 90 minutes on Day 3 of
Cycle 1. If it is well tolerated, the next dose of Bevacizumab will be given over 60
minutes on Day 2 of Cycle 2. If the Cycle 2 dose is well tolerated, the next doses of
Bevacizumab will be given over 30 minutes on Day 2 of Cycles 2-6. In addition to the study
drugs, you may also be given fluids by vein to help flush the kidneys, to help prevent
possible kidney damage. You may receive up to 6 cycles of treatment. Treatment will be
given on an outpatient basis. The injections for each daily treatment visit should take
less than 6 hours.
Up to 66 patients will take part in the study. All will be enrolled at M.D. Anderson.
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 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., 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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS) Rate
Outcome Time Frame:
2 Years
Safety Issue:
No
Principal Investigator
Susan O'Brien, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
MDACC-2005-0992
NCT ID:
NCT00448019
Start Date:
March 2007
Completion Date:
Related Keywords:
- Chronic Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia
- Fludarabine
- Cyclophosphamide
- Rituximab
- Bevacizumab
- CLL
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
