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] .
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NEWS HIGHLIGHTSMedia Articles Related to Campath (Alemtuzumab)
Effect Of Genzyme's LEMTRADA Maintained In Patients Beyond Two-Year Pivotal MS Studies
Source: Multiple Sclerosis News From Medical News Today [2013.03.28]
In more than 70 percent of patients, disability scores improved or remained stable over three years Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), have announced interim results from the first year of the extension study of LEMTRADA™ (alemtuzumab), being developed for the treatment for multiple sclerosis (MS)...
Data show new Roche leukemia drug may improve on Rituxan
Source: Yahoo! Health News [2013.05.16]
By Bill Berkrot (Reuters) - An experimental leukemia treatment that Roche Holding AG hopes will improve upon its best-selling cancer drug Rituxan delayed disease progression twice as long as chemotherapy, according to preliminary trial data releas...
Possible New Acute Leukemia Marker Treatment Target Identified
Source: Genetics News From Medical News Today [2013.05.15]
A study has identified microRNA-155 as a new independent prognostic marker and treatment target in patients with acute myeloid leukemia that has normal-looking chromosomes under the microscope (that is, cytogenetically normal acute myeloid leukemia, or CN-AML). The study was led by researchers at the Ohio State University Comprehensive Cancer Center - Arthur G...
Drug Combo Looks Promising For Chronic Lymphocytic Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.15]
Doctors at Dartmouth-Hitchcock's Norris Cotton Cancer Center (NCCC) have found a combination of drugs to potentially treat chronic lymphocytic leukemia (CLL) more effectively. The research was published online recently, and it will appear as a letter in the journal Leukemia, a publication of the prestigious Nature Publishing Group. The study helps address a basic problem of treating CLL...
Leukemia Drug Prevents Build-Up Of Toxic Brain Protein
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2013.05.14]
Researchers at Georgetown University Medical Center have used tiny doses of a leukemia drug to halt accumulation of toxic proteins linked to Parkinson's disease in the brains of mice. This finding provides the basis to plan a clinical trial in humans to study the effects...
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...
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 naïve 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.
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 >>
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