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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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Understanding Chronic Lymphocytic Leukemia

When you or a loved one first heard the diagnosis of chronic lymphocytic leukemia (CLL), you may have felt anxious and unsure about the future. However, many people find that learning about their condition can actually help relieve their fears and allow them to focus on maintaining their quality of life. Despite the difficulties, many people diagnosed with CLL cope well with their disease and benefit from treatment.

Chronic lymphocytic leukemia is a specific kind of blood cancer. It may be helpful to learn more about blood and blood cancer before learning more about CLL.

To understand what CLL is, let us first look at each word:

Chronic—slow to develop, long-lasting.

Lymphocytic—affecting the type of white blood cells called lymphocytes.

Leukemia—a cancer of the blood.

Chronic lymphocytic leukemia is a slowly developing cancer of the lymphocytes produced in the bone marrow. Abnormal lymphocytes accumulate in the blood and in various parts of the body. They may cause an enlargement of lymph nodes and of the liver and spleen. Abnormal lymphocytes also may impair the bone marrow's ability to produce sufficient normal blood cells.2-4

There are 3 different types of lymphocytes involved in CLL: B cells, T cells, and natural killer (NK) cells. B cells are by far the most common type found in CLL. Each of these 3 types of lymphocytes is produced in the same way, but they defend the body in different ways4:

The malignant lymphocytes in CLL5:

Other topics on this site related to CLL:

We hope the information presented within this site will help you learn more about the condition you are facing. Medical terms that may be new to you are linked to the Glossary. To quickly find information on a certain topic (for example, "symptoms") use the Search function or the Site Map to help you navigate the site.

Please be sure to read the important information on our Terms of Use page.

If you have any questions about the information on this site, we recommend you write them down so you can remember to discuss them with your doctor or nurse.

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).