|Closed||Chronic Lymphoid Leukemia (CLL)||Phase II||
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab and bevacizumab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving fludarabine together with rituximab and bevacizumab works in treating patients with B-cell chronic lymphocytic leukemia that has relapsed or not responded to treatment.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
Histologically confirmed B-cell chronic lymphocytic leukemia (CLL) as defined by WHO criteria
- Relapsed or refractory disease
- CD20-positive disease by flow cytometry
- Must exhibit active disease requiring treatment as per the NCI Working Group in CLL
- Measurable disease, defined as a combination of lymphocytosis ≥ 5,000/mm³ in peripheral blood and lymphocytosis ≥ 30% in bone marrow
- No fludarabine phosphate-refractory disease (no response of disease to ≥ 3 courses of a fludarabine phosphate-based regimen or relapse within 6 months of a fludarabine phosphate-based regimen)
No known CNS involvement or known CNS disease, except for treated brain metastases
Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening
- Treatment may include whole brain radiotherapy or radiosurgery (e.g., gamma knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician
- Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within the past 3 months are not eligible
- Stable dose anticonvulsants allowed
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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