Status:
COMPLETED
Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Primary Objective: * To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. S...
Detailed Description
DESCRIPTION OF RESEARCH Fludarabine and cyclophosphamide are chemotherapy drugs that are used in the treatment of CLL. Rituximab is a monoclonal antibody that binds to lymphoma cells and causes cell ...
Eligibility Criteria
Inclusion
- 16 years or older
- Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month of steroids or chemotherapy) are eligible
- Performance status of 3 or better (Appendix A)
- Adequate renal and hepatic function (creatinine \<2 mg%, bilirubin \<2mg%). Patient with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman but upper limits for creatinine even under these circumstances would be creatinine \< 3 mg% and bilirubin \< 6 mg%. Patients with Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%..
- A signed informed consent in keeping with policies of the hospital
Exclusion
- 1\) None
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00794820
Start Date
December 1 2003
End Date
December 1 2014
Last Update
May 8 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030