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