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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)

Multiple sclerosis: 10-year follow-up data on Lemtrada (alemtuzumab) presented at the AAN 2016 Annual Meeting
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.04.20]
Sanofi Genzyme, the specialty care global business unit of Sanofi, has announced that a new long-term analysis detailing 10 years of clinical efficacy of Lemtrada® (alemtuzumab) in people with...

Two-pronged attack on chemotherapy-resistant leukemia cells
Source: Cancer / Oncology News From Medical News Today [2016.05.19]
All stems from malignant transformed precursor lymphocytes, the blood's defense cells. Nowadays, four out of five young leukemia patients can be treated successfully with aggressive chemotherapy.

Study: 93 percent of advanced leukemia patients in remission after immunotherapy
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.04.28]
'Extraordinary' but short-term results from early-stage trial of engineered immune cells.

Risk factors identified for acute pancreatitis that can disrupt leukemia treatment
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.04.26]
Researchers have identified a rare genetic variation associated with a dramatically increased risk of severe acute pancreatitis in acute lymphoblastic leukemia (ALL) patients treated with the...

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2016.04.12]
The U.S. Food and Drug Administration has approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p...

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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)

Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma [Terminated]
Primary Objectives: 1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).

2. To examine the impact of in-vivo purging with Campath - 1H pre-autologous stem

transplantation for patients with PTCL. 3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.

4. To evaluate the role of Campath - 1H in the treatment minimal residual disease after

autologous transplantation for PTCL.

Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection [Completed]
The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).

Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia [Completed]
The goal of this clinical research study is to learn if giving CAMPATH-1H first as an injection into a vein, then as an injection under the skin can shrink or slow the growth of the disease in patients with chronic lymphocytic leukemia (CLL) who have already received standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H treatment are less severe by giving the drug first as an injection into a vein then as an injection under the skin.

Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy [Active, not recruiting]
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission. To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry. To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.

Phase II Study of Campath-1H Antibody to Treat Waldenstrom's Macroglobulinemia [Completed]

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: 2016-05-19

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