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Campath® Alemtuzumab - For Intravenous Use Only
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As a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) - See Things in a Whole New Light: Campath First Line - Campath® Alemtuzumab For Intravenous Use Only
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Clinical Trials

A clinical trial, commonly referred to as a clinical study, or research study, is designed to determine if a new drug or treatment is effective and will benefit patients. We encourage you to ask your doctor or nurse any questions you may have about clinical trials.

ClinicalTrials.gov provides up-to-date information about federally and privately supported clinical research studies, including:

The information you find on ClinicalTrials.gov should be used along with advice from your doctor. Before searching, you may want to learn more about Campath® (alemtuzumab) clinical trials:

Questions about clinical trials to ask your doctor

Here is a partial list of questions you should ask before considering entering a clinical trial for which you may be qualified. Be sure you understand and are comfortable with the answers to these questions before agreeing to participate in a study.

Other relevant clinical trial links

CancerTrialsHelp.org
www.cancertrialshelp.org
This is the official website of the Coalition of Cancer Cooperative Groups, a national network of cancer clinical trials specialists. Click on About Clinical Trials for answers to many of your questions, or Trial Search for trials sponsored by members of the coalition. After you've entered basic information (zip code, gender, etc), choose Leukemia from the disease list to view all of the pertinent clinical trials currently being conducted.

Center Watch
www.centerwatch.com
This extensive trial listing site includes more than 41,000 industry- and government-sponsored clinical studies. With the Patient and General Resources section, you can search listings by medical areas, or enter CLL as the key word and select your state or region for the trial location.

ClinicalTrials.gov
www.clinicaltrials.gov
This site is a service of the U.S. National Institutes of Health (NIH) that contains over 27,000 clinical studies sponsored by the NIH, other federal agencies, and private industry. This easy-to-use site allows you to search by entering keywords or to search by disease, location, treatment, or sponsor. Click on Resources for explanations of the elements of clinical trials, as well as links to other government health sites.

National Cancer Institute: Clinical Trials
www.cancer.gov/clinicaltrials
This is a comprehensive site with information about clinical trials-what they are, how they work, where and how to find one by cancer type, how to get into one-plus summaries of newsworthy results of completed trials. Click on Recent Developments for timely information on topics such as new treatments and insurance.

Veritas Medicine
www.veritasmedicine.com
Here you'll find a searchable online resource of ongoing clinical trials. You can register to be notified when new clinical trials that may be appropriate for you are open for enrollment. You can also sign up to receive free e-mail newsletters and articles written by leading physicians.

Indication and Important Safety Information

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

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 [see WARNINGS AND PRECAUTIONS (5.1)].

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 [see DOSAGE AND ADMINISTRATION (2) and WARNINGS AND PRECAUTIONS (5.2)].

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 [see DOSAGE AND ADMINISTRATION (2.2) and WARNINGS AND PRECAUTIONS (5.3)].

The most commonly reported adverse reactions are infusion reactions fever, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMV infection, other infections). In clinical trials, the frequency of infusion reactions was highest in the first week of treatment. Other commonly reported adverse reactions include vomiting, abdominal pain, insomnia and anxiety. The most commonly reported serious adverse reactions are cytopenias, infusion reactions, and immunosuppression/infections. See "Warnings and Precautions," and "Adverse Reactions" sections of full Prescribing Information.

Please see Full Prescribing Information (PDF).