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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...

FDA Approval for Alemtuzumab (Lemtrada) in MS
Source: Medscape NeurologyHeadlines [2014.11.15]
Alemtuzumab (Lemtrada) has received long-awaited FDA approval in relapsing multiple sclerosis.
FDA Approvals

At four years, treatment effect maintained in more than two-thirds of patients who received Lemtrada in multiple sclerosis pivotal studies
Source: Multiple Sclerosis News From Medical News Today [2014.09.12]
Sanofi and its subsidiary Genzyme has announced positive interim results from the second year of the extension study of Lemtrada(TM) (alemtuzumab) for multiple sclerosis.

Health Canada approves IMBRUVICA for chronic lymphocytic leukemia
Source: Cancer / Oncology News From Medical News Today [2014.11.20]
Janssen Inc. has announced Health Canada has approved IMBRUVICA (ibrutinib) for the treatment of the blood cancer chronic lymphocytic leukemia (CLL).

Anti-leukemia drug may also work against ovarian cancer
Source: Immune System / Vaccines News From Medical News Today [2014.11.20]
An antibody therapy already in clinical trials to treat chronic lymphocytic leukemia (CLL) may also prove effective against ovarian cancer - and likely other cancers as well, report researchers at...

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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 Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation [Recruiting]
After Campath induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.

The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.

Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic Sclerosis [Recruiting]
This phase I/II pilot trial seeks to demonstrate that prolonged administration of Campath-1H without prior marrow or stem cell harvesting can result in immunoablation similar to that achieved by hematopoietic stem cell transplantation (HSCT) from either bone marrow or peripheral blood stem cell sources in children and adolescents with severe treatment refractory systemic sclerosis (SSc).

Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis [Recruiting]
The purpose of this study is to test a novel strategy to prevent the clinical problem of secondary autoimmunity following alemtuzumab treatment of multiple sclerosis.

The hypothesis is that autoimmunity after alemtuzumab can be prevented by giving a drug that promotes thymic T cell regeneration (Palifermin, Kepivance«).

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.

more trials >>

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: 2014-11-20

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