Dosing and Administration

Clinical Studies

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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 Studies

Several clinical trials involving alemtuzumab are currently underway. For information, please call 1-888-84BAYER (Monday through Friday, 9 AM to 5 PM ET).

Clinical trial links

Here are links to Web sites with the latest information about ongoing clinical trials in CLL and studies using Campath.

www.cancertrialshelp.org
This is the official Web site of the Coalition of Cancer Cooperative Groups, a national network of cancer clinical trials specialists. Click on About Clinical Trials or Trial Search for trials sponsored by members of the coalition.

www.centerwatch.com
This extensive trial listing site includes more than 41,000 industry-and government-sponsored clinical studies. Listings can be searched by medical areas or enter CLL as the key word and select a state or region for the trial location.

www.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. Search by entering keywords or to search by disease, location, treatment, or sponsor.

www.cancer.gov/clinicaltrials
This is a comprehensive site with information about clinical trials. It contains summaries of newsworthy results of completed trials and timely information on topics such as new treatments and insurance.

www.trialscentral.org
While this site provides general information, its main function is as a clinical trials registry. The database under Clinical Trials contains an extensive listing of companies and institutions conducting clinical research studies. The Condition section in Clinical Trials presents broad categories, so if you select Cancers, you may need to spend a little time finding the specific information that is appropriate for you. You can also select your state to find links to local clinical trials.

www.veritasmedicine.com
This site is a searchable online resource of ongoing clinical trials. It is possible to register here for notification of new clinical trials that have open enrollment.

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).