Combination of Campath and Fludarabine Provides Benefit in CLL

Among people with previously treated, relapsed or refractory chronic lymphocytic leukemia (CLL), treatment with a combination of Campath® (alemtuzumab) and fludarabine results in better outcomes than treatment with fludarabine alone. These results were published in Lancet Oncology.

Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia. The American Cancer Society estimates that approximately 16,000 people will be diagnosed with CLL this year. Currently, there are approximately 95,000 people in theUnited Statesliving with CLL.

CLL is characterized by the production of atypical lymphocytes. Lymphocytes are specialized immune cells that exist in two forms: B- and T-cells. These cells are produced in the bone marrow and each serves a specific function in aiding the body fight infection.

The large majority of CLL cases involve mature B-lymphocytes that tend to live much longer than normal. B-lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. This results in overcrowding of these areas and suppression of the formation and function of blood and immune cells. Additionally, the cancerous lymphocytes themselves do not function normally, leading to a further reduction in the body’s ability to fight infection.

Campath is a monoclonal antibody that is targeted against B-cells. It has been designed to bind to specific sites on B-cells and cause the immune system to attack the cells to which it is bound.

To evaluate the combination of Campath and fludarabine in patients with previously treated CLL, researchers conducted a Phase III clinical trial among 335 patients. All study participants had CLL that had relapsed after prior treatment or that was resistant to prior treatment. Half the patients were treated with fludarabine alone and half were treated with fludarabine plus Campath.

  • Survival without cancer progression was 23.7 months among patients treated with fludarabine and Campath, versus 16.5 months among patients treated with fludarabine alone.
  • Overall survival was also better among patients treated with fludarabine and Campath.
  • Serious side effects were more common among patients given the combination treatment (33 percent versus 25 percent among patients treated with fludarabine alone).

These results suggest that the combination of Campath and fludarabine is more effective than fludarabine alone for patients with relapsed or refractory CLL.

Reference: Elter T, Gercheva-Kyuchukova L, Pylylpenko H et al. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a ramdomised phase 3 trial. Lancet Oncology. 2011;12:1204-13.

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