Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Leukemia

In brief

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell chronic lymphocytic leukemia.

Key facts

Study ID

NCT00086775

Run by

Bayer

Starts

2003-07-01

Expected to finish

2009-10-01

Last updated by the study team

2013-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Jackson Oncology Associates, PLLC — Jackson, Mississippi, United States
• Cancer Institute of New Jersey at Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Western Pennsylvania Cancer Institute — Pittsburgh, Pennsylvania, United States
• Hillman Cancer Center at University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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