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Campath (Alemtuzumab) - Summary

 
 



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] .

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] .

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  and WARNINGS AND PRECAUTIONS] .

 

CAMPATH SUMMARY

Campath (alemtuzumab) is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) directed against the 21-28 kD cell surface glycoprotein, CD52. Campath-1H is an IgG1 kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G).

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


See all Campath indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Campath (Alemtuzumab)

FDA approves Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis
Source: Multiple Sclerosis News From Medical News Today [2014.11.18]
Sanofi and its subsidiary Genzyme have announced that the U.S. Food and Drug Administration (FDA) has approved LemtradaTM (alemtuzumab) for the treatment of patients with relapsing forms of...

Discovery of possible genetic link in pediatric leukemia treatment-related cognitive issues
Source: Genetics News From Medical News Today [2014.12.13]
Common variations in four genes related to brain inflammation or cells' response to damage from oxidation may contribute to the problems with memory, learning and other cognitive functions seen in...

Potential to predict which patients are at risk of developing therapy-related acute myeloid leukemia
Source: Cancer / Oncology News From Medical News Today [2014.12.11]
For a small percentage of cancer patients, treatment aimed at curing the disease leads to a form of leukemia with a poor prognosis.

Combination chemotherapy for aggressive acute myeloid leukemia reduces adverse effects; older patient population benefits
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.11]
Patients who relapse in their battle with acute myeloid leukemia (AML) may benefit from a phase three study of therapies that combine an existing agent, cytarabine, with a newer compound, vosaroxin.

New kind of targeted drug shows promise for leukemia patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
A new type of cancer therapy that targets an oncometabolite produced dramatic results in patients with advanced leukemia in an early-phase clinical trial. The study, led by Eytan M.

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Published Studies Related to Campath (Alemtuzumab)

Alemtuzumab induction in renal transplantation. [2011.05.19]
BACKGROUND: There are few comparisons of antibody induction therapy allowing early glucocorticoid withdrawal in renal-transplant recipients. The purpose of the present study was to compare induction therapy involving alemtuzumab with the most commonly used induction regimens in patient populations at either high immunologic risk or low immunologic risk... CONCLUSIONS: By the first year after transplantation, biopsy-confirmed acute rejection was less frequent with alemtuzumab than with conventional therapy. The apparent superiority of alemtuzumab with respect to early biopsy-confirmed acute rejection was restricted to patients at low risk for transplant rejection; among high-risk patients, alemtuzumab and rabbit antithymocyte globulin had similar efficacy. (Funded by Astellas Pharma Global Development; INTAC ClinicalTrials.gov number, NCT00113269.).

Alemtuzumab versus interferon beta-1a in early relapsing-remitting multiple sclerosis: post-hoc and subset analyses of clinical efficacy outcomes. [2011.04]
BACKGROUND: Alemtuzumab is a humanised monoclonal antibody that depletes lymphocytes, causing long-term immunomodulation. In a 3-year, rater-blinded phase 2 study (the CAMMS223 study) in patients with relapsing-remitting multiple sclerosis (RRMS), alemtuzumab reduced relapse rate and the risk of sustained accumulation of disability compared with subcutaneous interferon beta-1a, and the mean expanded disability status scale (EDSS) score of the alemtuzumab cohort improved compared with baseline. Adverse events included infusion-associated reactions, predominantly mild to moderate infections, thyroid disorders, and immune thrombocytopenia. In this study, we further analysed the CAMMS223 data with the aim of determining whether demographic and baseline disease-related characteristics affect the beneficial effects of alemtuzumab. Additionally, we aimed to describe a new outcome measure in multiple sclerosis research: sustained reduction in disability... INTERPRETATION: Alemtuzumab reduced disease activity compared with interferon beta-1a in most of the analysed subgroups. Significantly greater numbers of patients experienced sustained improvement in disability after treatment with alemtuzumab than interferon beta-1a. The efficacy offered by alemtuzumab is a substantial advance in the treatment of multiple sclerosis. FUNDING: Genzyme and Bayer Schering Pharma. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Alemtuzumab induction therapy in highly sensitized kidney transplant recipients. [2011.03]
BACKGROUND: Immunosuppression for immunologically high-risk kidney transplant patients usually involves antithymocyte globulin induction with triple drug maintenance therapy. Alemtuzumab, a humanized anti-CD52 antibody, was expected to be a promising induction therapy agent for kidney transplantation. However, currently no consensus is available about its efficacy and safety. This study aimed to evaluate the efficacy and safety of alemtuzumab as immune induction therapy in highly sensitized kidney transplant recipients... CONCLUSION: Alemtuzumab induction therapy for highly sensitized kidney transplant recipients is an effective and safe protocol yielding an acceptable acute rejection rate.

Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation. [2010.11]
BACKGROUND: We performed a randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation. METHODS: Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C)...

A randomized trial of alemtuzumab versus antithymocyte globulin induction in renal and pancreas transplantation. [2009.09.27]
BACKGROUND.: Alemtuzumab and rabbit antithymocyte globulin (rATG) are commonly used for induction of immunsuppression for kidney and pancreas transplantation, but the two agents have not been compared directly. METHODS.: We conducted a prospective randomized single-center trial comparing alemtuzumab and rATG induction in adult kidney and pancreas transplantation in patients treated with similar maintenance immunosuppression...

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Clinical Trials Related to Campath (Alemtuzumab)

Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia [Recruiting]
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.

The use of G-CSF is justified by a possible increase in ADCC.

Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects [Not yet recruiting]
The purpose of this study is to treat prospectively documented clinic patients with treatment-refractory multiple sclerosis that are na´ve to alemtuzumab. Alemtuzumab shows efficacy and rate of serious adverse events (SAEs) which is equivalent or better than standard of care treatment strategies used previously for treatment-refractory multiple sclerosis.

Bendamustine Plus Alemtuzumab for Refractory Chronic Lymphocytic Leukemia (CLL) [Recruiting]
Patients will be treated with bendamustine at a fixed, standard dose. Escalating doses of alemtuzumab will be administered. A cycle is defined as a 4 week period with alemtuzumab administered on Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26.

Patients will be enrolled and treated within 28 days after screening. Alemtuzumab and bendamustine will be administered to cohorts of at least 3 patients. Dose escalation will occur by sequential cohort. Escalation of subsequent cohorts will occur no sooner than 28 days after the last patient in the cohort receives the first cycle Day 1 of treatment. Dose escalation will only occur in the absence of protocol specified dose limiting criteria at the current dose.

A Pilot Study of Alemtuzumab (Campath[R]) in Patients With Myelodysplastic Syndrome [Recruiting]
This study will evaluate the safety and effectiveness of a genetically engineered antibody, alemtuzumab (Campath[R]) on patients with myelodysplastic syndrome. MDS is made up of malignant stem cell disorders that can mean low levels of red blood cells-that is, anemia-and low counts of white blood cells and platelets. Patients with MDS are at risk for infection, spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can produce some blood cells, patients with MDS experience a decrease in production of blood cells. Alemtuzumab recognizes specific types of white cells called lymphocytes and destroys them. This study will examine not only the usefulness of the medication but also the side effects in patients with MDS.

Patients ages 18 to 72 who have MDS that requires transfusions and who do not have HIV or a life expectancy of less than 6 months may be eligible for this study. Screening tests include a complete physical examination and medical history. There will be a collection of about 8 tablespoons of blood for analysis of blood counts as well as liver, kidney, and thyroid function; a pregnancy test; an electrocardiogram (EKG) to measure electrical activity of the heartbeat; an echocardiogram (ECHO), which uses sound waves to evaluate heart function; wearing of a Holter monitor for 24 hours while the electrical activity of the heart is recorded; and a bone marrow biopsy. Patients should not receive any vaccines when taking alemtuzumab or for at least 12 months after the last dose. In addition, patients should not take the herbal supplements Echinacea purpurea or Usnea 2 weeks before beginning the study and during it.

For the study, all patients will receive a test dose of 1 mg of alemtuzumab infused into a vein during the course of 1 hour. If the dose is tolerated, the medication will be given at 10 mg doses into the vein for 10 days, as an infusion of 2 hours. Blood samples of 2 tablespoons will be taken daily, and vital signs will be measured daily. The ECHO and 24-hour Holter monitoring will be repeated after patients receive the last dose of the medication. Because suppression of the immune system results from a decrease in white cells that fight infections, patients will take medications to protect them against infections and to treat them if infections occur. If needed, patients will receive blood transfusions for their MDS. Side effects of alemtuzumab involve a temporarily significant lowering of the number of red blood cells, white cells, and platelets. Side effects of the infusion can be rigidity, or stiffness, and fever, as well as risks of infections resulting from the decrease of white blood cells. Blood counts and reactions to all procedures will be carefully monitored throughout the study. After patients receive the last dose of alemtuzumab, they will have follow-up by their referring doctor or at NIH. They must be able to return to NIH after 1 month, 3 months, 6 months, and annually for 5 years after the study. At follow-up visits, there will be blood tests to reevaluate blood counts and test for the presence of viruses. Blood tests will be done weekly for the first 3 months after patients have completed taking alemtuzumab, every other week until 6 months, and then annually for 5 years. There will also be a repeat ECHO at the 3-month visit, and a repeat bone marrow biopsy at the 5-month and 12-month follow-up visits, and as needed after that.

This study may or may not have a direct benefit for participants. For some, the antibody may improve blood counts and decrease the need for transfusions. Knowledge gained in the study may help people in the future.

Alemtuzumab and Rituximab in Aplastic Anemia [Recruiting]

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Reports of Suspected Campath (Alemtuzumab) Side Effects

Pyrexia (24)Death (22)Cytomegalovirus Infection (15)Pancytopenia (13)C-Reactive Protein Increased (12)Adenovirus Infection (12)Pneumonia (12)Dyspnoea (12)Infection (11)Pleural Effusion (11)more >>


Page last updated: 2014-12-13

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