Alemtuzumab

Generic Name: Alemtuzumab

Brand Names: Campath, Lemtrada, MabCampath

Drug Type: Biotech

Chemical Formula: -

CAS Number: 216503-57-0

Unique Ingredient Identifier: 3A189DH42V

Background: 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.

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

Associated Therapies: Conditioning regimens for allogeneic stem cell transplantation therapy

Clinical Trials

HSCT for High Risk Inherited Inborn Errors

Phase 2

Completed

Conditions: Globoid Cell Leukodystrophy
I-Cell Disease
Adrenoleukodystrophy
Wolman Disease
Sanfilippo Syndrome
GM1 Gangliosidosis
Metachromatic Leukodystrophy
Tay Sachs Disease
Sandhoffs Disease

Interventions: Drug: Clofarabine
Procedure: Total body Irradiation
Drug: Melphalan
Biological: Hematopoietic Stem Cell Transplantation
Drug: Alemtuzumab
Drug: mycophenylate mofetil
Device: Cyclosporine A
Drug: Hydroxyurea

First Posted Date: 2006-10-03

Last Posted Date: 2019-07-11

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 38

Registration Number: NCT00383448

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia

Phase 2

Conditions: Chronic Lymphocytic Leukemia

Interventions: Procedure: allogeneic stem cell transplantation
Drug: Alemtuzumab

First Posted Date: 2006-06-16

Last Posted Date: 2009-01-29

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 82

Registration Number: NCT00337519

Locations: 🇩🇪
Uniklinikum Carl Gustav Carus, Dresden, Germany
🇩🇪
Klinikum Chemnitz gGmbH, Chemnitz, Germany
🇩🇪
Deutsche Klinik für Diagnostik GmbH, Wiesbaden, Germany

Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia

Not Applicable

Conditions: B-Cell Chronic Lymphocytic Leukemia

First Posted Date: 2006-06-13

Last Posted Date: 2006-07-25

Lead Sponsor: Tawam Hospital

Target Recruit Count: 60

Registration Number: NCT00336206

Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation

Phase 4

Completed

Conditions: Graft Rejection

Interventions: Drug: Alemtuzumab
Drug: Anti-Thymocyte Globulin

First Posted Date: 2006-05-29

Last Posted Date: 2018-09-06

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 222

Registration Number: NCT00331162

Locations: 🇺🇸
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States

Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL

Phase 1

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Rituximab
Drug: Alemtuzumab

First Posted Date: 2006-05-26

Last Posted Date: 2016-05-13

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 29

Registration Number: NCT00330252

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States