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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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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
This site is a service of the US 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.

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

The goals of a trial
Who is eligible to participate
Where the trial will take place
Phone numbers or other contact information

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 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.

What is the purpose of the study?
What are the risks involved?
Will I be in any discomfort or pain?
What kinds of tests, procedures, or treatments will be performed? How many and how often?
Will I be able to see my own doctor during the trial?
What costs will I be responsible for?

Other relevant clinical trial links

CancerTrialsHelp
This is the official Web site of the Coalition of Cancer Cooperative Groups, a national network of cancer clinical trial 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.

CenterWatch
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.

National Cancer Institute: Clinical Trials
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
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.

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).