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Brand name(s): Campath®

• Approved for B-cell chronic lymphocytic leukemia

Full prescribing information ³ is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On September 19, 2007, the U.S. Food and Drug Administration (FDA) expanded the labeling and granted regular approval for single-agent alemtuzumab (Campath®, made by Genzyme Corporation) for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Alemtuzumab was initially approved in 2001 under accelerated approval regulations and the study described below fulfills the post-marketing commitment to verify its clinical benefit.

In the study, 297 B-CLL patients received either alemtuzumab (after dose escalation, 30 mg intravenously over two hours three times/week on alternate days for 12 weeks) or chlorambucil (40 mg/m2 orally every 28 days for up to 12 cycles.) Patients had Rai stage I - IV CLL, were previously untreated with chemotherapy, and had evidence of progressive disease at entry. Patients receiving alemtuzumab experienced a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to those receiving chlorambucil (median PFS: 14.6 vs. 11.7 months; hazard ratio 0.58, p=0.0001 two-sided stratified log-rank test). Patients receiving alemtuzumab also demonstrated an increased overall response rate (83 percent vs. 55 percent; p<0.0001) and an increased complete response rate (24 percent vs. 2 percent; p<0.0001) compared to those receiving chlorambucil. No differences were seen in the FDA-requested interim analysis of survival (24 deaths in each arm.)

The safety profile observed in this trial was consistent with the previously described safety profile provided in the product label ³.

A type of monoclonal antibody used in the treatment of leukemia. Monoclonal antibodies are laboratory-produced substances that can locate and bind to cancer cells. Also called Campath-1H.

An indolent (slow-growing) cancer in which too many immature lymphocytes (white blood cells) are found mostly in the blood and bone marrow. Sometimes, in later stages of the disease, cancer cells are found in the lymph nodes and the disease is called small lymphocytic lymphoma. Also called CLL.

Into or within a vein. Intravenous usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein. Also called IV.

The main result that is measured at the end of a study to see if a given treatment worked (e.g., the number of deaths or the difference in survival between the treatment group and the control group). What the primary endpoint will be is decided before the study begins.

The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works. Also called PFS.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.