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

Non-Myeloablative Allogeneic Stem Cell Transplantation

Not Applicable

Completed

Conditions: Lymphoma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Rituximab
Procedure: Allogeneic Stem Cell Infusion
Drug: Alemtuzumab

First Posted Date: 2007-09-06

Last Posted Date: 2011-12-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 49

Registration Number: NCT00525876

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

Phase 2

Terminated

Conditions: Lymphoma

Interventions: Drug: Campath-1H
Drug: G-CSF
Drug: GM-CSF
Drug: BCNU
Drug: Stem Cell Transplant
Drug: Preparative Regimen for Allogenic Stem Cell Transplantation
Drug: Cytarabine
Drug: Etoposide
Drug: Melphalan
Drug: Campath
Drug: Fludarabine
Drug: Cyclophosphamide
Radiation: Low dose total body irradiation

First Posted Date: 2007-07-25

Last Posted Date: 2011-11-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 27

Registration Number: NCT00505921

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias

Phase 2

Terminated

Conditions: Autoimmune Cytopenias

First Posted Date: 2007-05-11

Last Posted Date: 2009-06-22

Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Target Recruit Count: 30

Registration Number: NCT00472433

Locations: 🇹🇭
Phramongkutklao Hospital, Bangkok, Thailand

Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Fludarabine
Drug: Campath
Procedure: Transplant

First Posted Date: 2007-04-19

Last Posted Date: 2013-09-06

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 86

Registration Number: NCT00462332

Locations: 🇮🇹
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE, Lecce, Italy
🇮🇹
Ospedale Regionale A. Pugliese, Catanzaro, Italy
🇮🇹
Universita di Ferrara, Ferrara, Italy

and more 20 locations