Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00794820

Run by

M.D. Anderson Cancer Center

People needed

66

Starts

2003-12-01

Expected to finish

2014-12-01

Last updated by the study team

2018-05-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• None

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.