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

CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

Phase 2

Completed

Conditions: Peripheral T-Cell Lymphoma

Interventions: Drug: Alemtuzumab

First Posted Date: 2013-03-07

Last Posted Date: 2013-03-07

Lead Sponsor: University of Göttingen

Target Recruit Count: 41

Registration Number: NCT01806337

Belatacept Early Steroid Withdrawal Trial

Phase 4

Completed

Conditions: Renal Transplantation

Interventions: Drug: Alemtuzumab
Drug: rabbit antithymocyte globulin
Drug: Tacrolimus
Drug: Belatacept
Drug: Mycophenolate mofetil
Drug: early cessation of steroids

First Posted Date: 2012-11-20

Last Posted Date: 2021-07-28

Lead Sponsor: University of Cincinnati

Target Recruit Count: 316

Registration Number: NCT01729494

Locations: 🇺🇸
University of Wisconsin-Madison, Madison, Wisconsin, United States
🇺🇸
Tampa General Hospital, Tampa, Florida, United States
🇺🇸
The Christ Hospital, Cincinnati, Ohio, United States

and more 5 locations

Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis

Phase 1

Terminated

Conditions: Multiple Sclerosis

Interventions: Drug: Palifermin
Drug: Alemtuzumab

First Posted Date: 2012-10-24

Last Posted Date: 2019-04-30

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Target Recruit Count: 40

Registration Number: NCT01712945

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom

High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior Treatment

Phase 2

Terminated

Conditions: Multiple Sclerosis

Interventions: Drug: Alemtuzumab
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2012-09-05

Last Posted Date: 2013-11-25

Lead Sponsor: Seah Lim M.D.

Target Recruit Count: 1

Registration Number: NCT01679041

Locations: 🇺🇸
Texas Oncology, Amarillo, Texas, United States
🇺🇸
Dr Ruby Saulog, Amarillo, Texas, United States
🇺🇸
Amarillo Diagnostic Clinic, Amarillo, Texas, United States

Campath-1h Phase I/II Pilot Trial as Immunoablative Therapy for Refractory Systemic Sclerosis

Withdrawn

Conditions: Scleroderma

First Posted Date: 2012-07-12

Last Posted Date: 2023-09-13

Lead Sponsor: Children's Hospital Los Angeles

Registration Number: NCT01639573

A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

Phase 1

Completed

Conditions: Lymphoma
Renal Cell Carcinoma
Gastrointestinal Tumor
Hepatic Tumor
Wilms Tumor
Clear Cell Carcinoma
Melanoma
Neuroblastoma
Rhabdomyosarcoma
Ewing Sarcoma

Interventions: Drug: alemtuzumab
Drug: fludarabine
Drug: sirolimus
Drug: Busulfan
Drug: melphalan
Biological: stem cells
Device: CliniMACS

First Posted Date: 2012-06-21

Last Posted Date: 2020-10-19

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 23

Registration Number: NCT01625351

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects

Phase 1

Conditions: Multiple Sclerosis

Interventions: Drug: Alemtuzumab
Drug: Alemtuzumab immunotherapy

First Posted Date: 2012-06-21

Last Posted Date: 2014-03-11

Lead Sponsor: Samuel Forrester Hunter, MD, PhD

Target Recruit Count: 60

Registration Number: NCT01624714

Locations: 🇺🇸
Advanced Neurosciences Institute, Franklin, Tennessee, United States

Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation

Phase 2

Terminated

Conditions: Myeloid Malignancy
Bone Marrow Failure Syndrome
Severe Immune Dysregulation
Metabolic Disease
Transfusion-dependent Red Blood Cell (RBC) Defect
Congenital Immunodeficiency

Interventions: Drug: Busulfan
Drug: Alemtuzumab
Drug: Fludarabine
Drug: Clofarabine

First Posted Date: 2012-05-11

Last Posted Date: 2020-02-26

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 16

Registration Number: NCT01596699

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Phase 2

Terminated

Conditions: Leukemia
Lymphoma
Myeloma
Myeloproliferative Diseases

Interventions: Drug: Fludarabine
Drug: Melphalan
Drug: Alemtuzumab
Procedure: Stem Cell Infusion
Drug: Tacrolimus
Drug: Methotrexate
Drug: G-CSF
Procedure: Low Dose Donor T-Cells
Procedure: High Dose Donor T-Cells

First Posted Date: 2012-01-25

Last Posted Date: 2016-03-17

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 16

Registration Number: NCT01518153

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

Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD)

Phase 1

Active, not recruiting

Conditions: Sickle Cell Disease

Interventions: Procedure: Allogeneic Non-Myeloablative Stem Cell Transplantation
Drug: Alemtuzumab
Drug: Sirolimus

First Posted Date: 2011-12-26

Last Posted Date: 2024-07-23

Lead Sponsor: University of Illinois at Chicago

Target Recruit Count: 45

Registration Number: NCT01499888

Locations: 🇺🇸
University of Illinois at Chicago, Chicago, Illinois, United States

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