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Chronic Lymphoid Leukemia (CLL)

Fludarabine + Rituximab/Avastin for Relapsed/Refractory B-cell CLL (FHCRC-2278)
A Phase II Study of Fludarabine (F), Rituximab (R) and Avastin (A) Followed by RA Maintenance Therapy in Patients with Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (CLL)
Status Conditions Phase Study ID
Closed Chronic Lymphoid Leukemia (CLL) Phase II FHCRC-2278
NCT00845104
Summary

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.


Investigator
John Pagel, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
Last Updated
May 27, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.