Overview

Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
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. Secondary Objective: - To evaluate remission duration and survival.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genentech, Inc.
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Criteria
Inclusion Criteria:

1. 16 years or older

2. Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month
of steroids or chemotherapy) are eligible

3. Performance status of 3 or better (Appendix A)

4. 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%..

5. A signed informed consent in keeping with policies of the hospital

Exclusion Criteria:

1) None