Alemtuzumab

Overview

Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.

Background

Indication

用于烷化剂氟达拉滨（fludarabine）治疗失败的B细胞性慢性淋巴细胞白血病患者；亦可用于复发缓解型多发性硬化症治疗。

Associated Conditions

B-Cell Chronic Lymphocytic Leukemia
Kidney Transplant Rejection
Relapsing Remitting Multiple Sclerosis (RRMS)
Secondary Progressive Multiple Sclerosis (SPMS)
Steroid Refractory Acute Graft Versus Host Disease
T-cell Prolymphocytic Leukemia (T-PLL)
Refractory Autoimmune Hemolytic Anemia
Refractory Idiopathic thrombocytopenic purpura

Title	Posted	Study ID	Phase	Status	Sponsor
Donor Stem Cell Transplantation for Congenital Immunodeficiencies	2007/01/24	NCT00426517	Early Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML	2006/12/28	NCT00416884	Phase 2	Terminated	OHSU Knight Cancer Institute
Stem Cell Transplant in Sickle Cell Disease and Thalassemia	2006/12/07	NCT00408447	Phase 2	Active, not recruiting	Columbia University
HSCT for High Risk Inherited Inborn Errors	2006/10/03	NCT00383448	Phase 2	Completed	Masonic Cancer Center, University of Minnesota
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"	2006/08/18	NCT00365846	Phase 2	Completed	University of Wisconsin, Madison
Vitalis Study - Observational Study on the Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia (B-CLL)	2006/06/27	NCT00344825	N/A	Completed	Genzyme, a Sanofi Company
Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia	2006/06/16	NCT00337519	Phase 2	UNKNOWN	Charite University, Berlin, Germany
Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia	2006/06/13	NCT00336206	Not Applicable	UNKNOWN	Tawam Hospital
Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation	2006/05/29	NCT00331162	Phase 4	Completed	Wake Forest University Health Sciences
Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL	2006/05/26	NCT00330252	Phase 1	Completed	Dana-Farber Cancer Institute

Title

Posted

Study ID

Phase

Status

Sponsor

Donor Stem Cell Transplantation for Congenital Immunodeficiencies

2007/01/24

NCT00426517

Early Phase 1

Completed

National Institute of Allergy and Infectious Diseases (NIAID)