Advanced MRI Measures of Repair in Alemtuzumab Treated Patients (iCAMMS-IST)

University of British Columbia

Status and phase

Completed

Phase 3

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Drug: MabCampath-1h

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01307332

H10-02482

142402 (Other Identifier)

Details and patient eligibility

About

There are two parts to this investigator sponsored trial (IST):

To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.

Full description

Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous System (CNS). There are many forms of MS; although the majority are Relapsing Remitting (RRMS) representing approximately 80% of the cases. The disease appears to be more inflammatory in RRMS as manifested by an increase in Gadolinium (Gd) enhancement on MRI and an increase in inflammatory bio-assay markers.

Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and sustained lymphocyte depletion and is approved for the treatment of B-cell chronic lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH.

There are two parts to this Investigator Sponsored Trial (IST):

To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.
To provide serum samples for the University of Southern California (USC) ICAM125 lymphocyte recovery study.

Enrollment

27 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed, informed consent form
Age 18 to 50 years old (inclusive)
Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 10 years of screening
Onset of MS symptoms within 15 years of screening
Neurostatus (EDSS) score 0.0 to 5.0 (inclusive)
2 MS attacks (first episode or relapse) occurring in the 24 months prior to screening, with 1 attack in the 12 months prior to screening, with objective neurological signs confirmed by a physician.

Exclusion criteria

Received prior therapy for MS other than corticosteroids within 28 days of screening; e.g., interferon's, IV immunoglobulin, and glatiramer acetate
Exposure to natalizumab within 6 months of screening
Any prior exposure to mitoxantrone, mycophenolate mofetil, azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, rituximab, or any other immunosuppressive agent other than systemic corticosteroid treatment
Has any progressive form of MS
History of malignancy (exception for basal cell skin carcinoma)
Previous hypersensitivity reaction to other immunoglobulin product
Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
CD4+, CD8+, or CD19+ (i.e., absolute CD3+CD4+, CD3+CD8+, or CD19+/mm3) count <LLN at Screening; if abnormal cell count(s) return to within normal limits, eligibility may be reassessed
Seropositivity for human immunodeficiency virus (HIV)
Significant autoimmune disease (e.g, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders; vasculitis; inflammatory bowel disease; severe psoriasis)
Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies
Active infection
Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
Infection with hepatitis B virus or hepatitis C virus
Of childbearing potential with a positive serum pregnancy test
Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period
Major psychiatric disorder that is not adequately controlled by treatment
Epileptic seizures that are not adequately controlled by treatment
Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results
Medical, psychiatric, cognitive, or other conditions
Confirmed platelet count the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at 100,000/L within the past year on a sample without clumping
Prior history of invasive fungal infections
Cervical high risk human papilloma virus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS).
Seropositive for Trypanosoma cruzi or the Human T-lymphotropic virus type I or type II (HTLV-I/II) (testing required in endemic regions only)
Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by alemtuzumab treatment
Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome.