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As a single agent for B-cell chronic lymphocytic leukemia (B-CLL) - Change Your Thinking: Campath First Line(1)
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Glossary

Abdomen–Inside of the body below the chest; contains the digestive system, liver, spleen, kidneys, and female reproductive organs.

Alkylating agent–An anticancer drug that interferes with cancer cell division by binding to DNA.

Anemia–A shortage of hemoglobin within the blood.

Antigen–Foreign matter that provokes an immune response in the body it invades.

Apoptosis–A process whereby a cell causes its own breakdown (death).

Autoimmune–A condition where the immune system attacks some part of the body that it should not consider as foreign, eg, rheumatoid arthritis.

B cell–A type of lymphocyte that matures in the bone marrow and goes on to produce antibodies if stimulated by the right antigen.

B-symptoms–Drenching night sweats, unexplained loss of 10% of body weight, marked weakness, and a fever of more than 100°F (38°C) lasting for more than a week.

Binet–A staging system for lymphomas.

Bone marrow–Tissue contained within the central cavity of bones. It is responsible for the production of blood cells.

CD–Stands for "cluster of differentiation." Used with a number (eg, CD52) to name a specific antigenic marker found on lymphocytes.

Cells–Cells are the basic unit of life. Some organisms, such as bacteria, are just individual free-living cells. Other multicellular organisms, such as humans, have many different kinds of cells.

Chemotherapy–The use of drugs to treat cancers.

Chromosomes–Structures within a cell that carry its genetic information in the form of DNA.

CLL–Chronic lymphocytic leukemia; a cancer of the blood caused by the accumulation of affected B cells in the body that typically progresses slowly.

Complete response–The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.

Contrast agent–A dye or other substance that helps show abnormal areas inside the body.

CT–Computed tomography; a medical imaging technique that uses x-rays to form very clear pictures of the inside of the body that appear as slices down its length.

Diagnosis–The determination of the nature of a disease through its signs and symptoms and the use of specific tests.

Differentiation–Process of change in which stem cells divide and mature to form fully functioning specialized cells.

DNA–A chemical that is made up of a chain of smaller chemicals called nucleotides. There are 4 different kinds of nucleotides in DNA and the order in which they are arranged forms the genetic code. The nucleotides also form pairs opposite each other when they are arranged as a double helix in a chromosome.

First-degree relatives–Children, parents, brothers, and sisters.

Flow cytometry–Automated system for detecting the binding to cells of antibodies labeled with a fluorescent dye.

Fludarabine therapy–A form of CLL treatment that involves a chemotherapy that interferes with the making of DNA so new leukemia cells cannot grow and shortens the life of existing leukemia cells.

Immune System–The organs responsible for the ability of the body to fight infection by recognizing invading bacteria, viruses, and fungi as foreign matter and destroying them.

Immunophenotyping–A way of characterizing cells by the antibodies that they display on their surface.

Infection–Invasion of the body by a bacterium, virus, or fungus.

Irradiated–Treated with radiation.

Leukemias–Cancer of blood-forming tissue, which causes overproduction of white blood cells.

Liver–Large organ situated at the top of the abdomen that has many important functions, especially with regard to the metabolism of the food we eat and the breakdown of toxins.

Lymph node–Swellings along the lymphatic system where lymph (a clear fluid that resembles blood plasma) is filtered to remove foreign material.

Lymphoid–Tissue associated with the lymphatic system, including tonsils and adenoids.

Lymphatic system–A network of tubes—like the blood system, but without a pump—that carries a fluid called lymph all around the body.

Lymphocyte–A type of white blood cell involved in the immune system. There are 3 kinds: B, T, and NK cells.

Malignant–Cancerous growth that invades surrounding tissue and spreads to other parts of the body.

Markers–Specific antigens that are found on lymphocytes. Different markers are associated with lymphocytes found in the various types of leukemia/lymphoma.

Metastasis–A secondary tumor formed when a cancer cell breaks off from the original site, travels around the bloodstream, and implants in another organ.

Monoclonal antibody–An artificially produced pure form of an antibody. Normally, an antigen will cause many slightly different forms of an antibody to be formed.

MRI–Magnetic resonance imaging; a medical imaging technique that uses strong magnet fields and high-frequency radio waves to form very clear pictures of the inside of the body that can be viewed in any direction.

Mutations–An alteration in the genetic material of a cell caused by change in the sequence of nucleotides in its DNA.

Myeloid–Refers to the bone marrow. Myeloid stem cells go on to form red blood cells, platelets, and white blood cells that are not lymphocytes.

NK cells–Natural killer cells; a type of lymphocyte that recognizes and kills cells infected with a virus.

Nucleus–Part of the cell that contains the chromosomes.

Overall Response–The number of patients who had either a complete response or partial response.

Oxygen–A gas that makes up 20% of the atmosphere. It plays an essential role in the ability of the body to produce energy from food.

Partial Response–A decrease in the extent of cancer in the body, in response to treatment.

Pathologist–A doctor who assists in the diagnosis and treatment of disease by studying samples of body tissues and fluid.

Platelets–Tiny blood cells that are important in blood clotting.

Pluripotent–A description of the stem cells that can go on to form any other type of blood cell.

Proteins–The basic building block of the body. As well as forming the structure of tissues, such as muscle, they also act as enzymes controlling the chemical processes of the body.

Purine analog–An anticancer drug that interferes with cancer cell division and causes their death. The enzyme that is responsible for DNA replication tries to use the analog rather than the proper purine, and thus does not function correctly.

Radiology–The use of medical imaging techniques such as x-ray, CT, ultrasound, and MRI for diagnosis.

Radiotherapy–The use of radiation to kill cancer cells. X-rays and gamma-rays are the most commonly used forms.

Rai–A staging system for lymphoma.

Refractory–A cancer that does not respond to particular treatment.

Remission–Reduction in the severity or temporary disappearance of a cancer.

Response rate–The proportion of patients in which a treatment has an effect on cancer. Responses can be partial or complete.

Spleen–An organ located just below the liver that screens the blood for foreign particles and old blood cells.

Staging–The use of a set of criteria, such as spread of disease, to decide how far a cancer has advanced so that the correct treatment can be offered.

Stem cell–Cells that divide to produce all the different kinds of cells within an organ. For blood cells, these are mostly found in the marrow, but some move into the blood.

Symptom–An indication of disease that a patient reports.

T cell–A type of lymphocyte that matures in the thymus and binds to a specific antigen if it encounters it in the body.

Thrombocytopenia–A shortage of platelets within the blood.

Tumor–An abnormal growth of solid tissue that may be malignant or benign.

Ultrasound–A technique that uses high-frequency sound waves to form an image of the inside of the body.

Viruses–Particles made up of a shell of protein containing a core of DNA or RNA. They can only reproduce by taking over the mechanisms of a cell that they have infected. Viruses cause diseases such as mumps, colds, influenza, and chicken pox.

Indications & Usage

Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).

Important safety information
WARNING: CYTOPENIAS, INFUSION REACTIONS, and INFECTIONS

Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia.

Infusion Reactions: Campath administration can result in serious, including fatal, infusion reactions. Carefully monitor patients during infusions and withhold Campath for Grade 3 or 4 infusion reactions. Gradually escalate Campath to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days.

Infections: Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections.

In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. The following serious, including fatal, infusion reactions have been identified in post-marketing reports: syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, cardiac arrhythmias, myocardial infarction, acute cardiac insufficiency, cardiac arrest, angioedema, and anaphylactoid shock.

Prolonged myelosuppression have been reported in patients receiving Campath. Campath treatment results in severe and prolonged lymphopenia with a concomitant increased incidence of opportunistic infections. Assess CD4+ counts after treatment until recovery to ≥ 200 cells/µL. Obtain complete blood counts (CBC) at weekly intervals during Campath therapy and more frequently if worsening anemia, neutropenia, or thrombocytopenia occurs. Withhold Campath for severe cytopenias (except lymphopenia). Discontinue for autoimmune cytopenias or recurrent/persistent severe cytopenias (except lymphopenia).

Administer only irradiated blood products to avoid transfusion associated Graft versus Host Disease (TAGVHD), unless emergent circumstances dictate immediate transfusion.

Routinely monitor patients for CMV infection during Campath treatment and for at least 2 months following completion of treatment. Withhold Campath for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia. Initiate therapeutic ganciclovir (or equivalent) for CMV infection or confirmed CMV viremia.

Do not administer live viral vaccines to patients who have recently received Campath.

The most common adverse reactions (≥ 10%) were infusion reactions, cytopenias, cytomegalovirus (CMV) and other infections, nausea, emesis, diarrhea, and insomnia.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see full Prescribing Information (PDF).