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Patients With Advanced B-CLL Leukemia Double Life Expectancy in Clinical Trial

Patients With Advanced B-CLL Leukemia Double Life Expectancy in Clinical Trial
M. D. Anderson News Release 05/16/02

Life expectancy for patients with B-cell chronic lymphocytic leukemia (B-CLL) doubled from eight to 16 months in a worldwide clinical trial of alemtuzumab (Campath(r)), according to lead researcher Dr. Michael J. Keating of The University of Texas M. D. Anderson Cancer Center.
 
The first full report of the pivotal clinical trial which lead to accelerated FDA approval of alemtuzumab in May 2001 is to be published in the May 15 issue of Blood, the journal of the American Society of Hematology.

The article also presents follow-up data reporting a 32-month life expectancy among the 33 percent of trial enrollees who responded to alemtuzumab, said Dr. Keating, the lead author.

The study involved 93 B-CLL patients at 21 centers worldwide. All study participants had received previous therapy with alkylating agents and were no longer responding to fludarabine phosphate, the single most effective agent for second line treatment of CLL patients.  Investigators observed an overall response rate of 33 percent (31 of 93 patients), including both complete and partial response with the alemtuzumab.

When the latest 12-month follow-up was completed in February 2001, 19 of the 31 patients (61 percent) who responded to treatment were still alive up to 32 months after ending therapy, Dr. Keating said. Overall median survival was 16 months.

"Historically, once patients failed other forms of treatment, they had little hope. Median life expectancy was 8-12 months," Dr. Keating said. "This new survival data is good  news for patients with refractory B-CLL, who until now, have had no other approved therapy options available."

B-CLL is characterized by an accumulation of malignant lymphocytes that often bear the CD52+ antigen, in the bone marrow, blood and other tissues. As a result of the accumulation of malignant lymphocytes, bone marrow dysfunction and enlargement of the lymph nodes, liver, and spleen may occur. 

Alemtuzumab selectively targets the CD52+ antigen on the malignant lymphocytes, inducing antibody-dependent lysis (killing) of the malignant cells. This results in the removal of the malignant lymphocytes from the blood, bone morrow, and other affected organs.

B-CLL is the most prevalent form of adult leukemia. It affects approximately 60,000 people in the United States and another 60,000 in Europe annually.

05/16/02


© 2014 The University of Texas MD Anderson Cancer Center