- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01307332
Advanced MRI Measures of Repair in Alemtuzumab Treated Patients (iCAMMS-IST)
Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
British Columbia
-
Vancouver, British Columbia, Canadá, V6T 2B5
- University of British Columbia Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: MabCampath-1h
Single arm, single cohort study, all subjects will be dosed with alemtuzumab.
|
Drug:10 mg/mL alemtuzumab intravenous infusion.
Form: Sterile, clear, colorless solution.
Dosage: 2 cycles.
Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in normal appearing white matter from baseline through month 24.
Periodo de tiempo: 24 months
|
The MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.
|
24 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To identify specific changes in T cell subsets and functions in Relapsing Remitting Multiple Sclerosis from baseline through month 48.
Periodo de tiempo: 48 months
|
Analyzing changes is immune responsiveness may reveal critical information about the mechanisms by which alemtuzumab acts, confirm the importance of specific immune cell types or molecules as targets for alemtuzumab treatment or may also be useful for monitoring drug effectiveness and safety.
|
48 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anthony Traboulsee, MD, University of British Columbia
Publicaciones y enlaces útiles
Publicaciones Generales
- Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.
- Coles AJ, Cox A, Le Page E, Jones J, Trip SA, Deans J, Seaman S, Miller DH, Hale G, Waldmann H, Compston DA. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006 Jan;253(1):98-108. doi: 10.1007/s00415-005-0934-5. Epub 2005 Jul 27.
- CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. doi: 10.1056/NEJMoa0802670.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Esclerosis múltiple
- Enfermedades del sistema inmunológico
- RRMS
- EM
- Enfermedades del Sistema Nervioso
- Enfermedades autoinmunes
- Alemtuzumab
- Células T
- Esclerosis múltiple remitente recurrente
- Desmielinización
- Enfermedades desmielinizantes
- Remielinización
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Tolerogenic
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Enfermedades autoinmunes
- Esclerosis múltiple
- Esclerosis
- Esclerosis Múltiple Recurrente-Remitente
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Alemtuzumab
Otros números de identificación del estudio
- H10-02482
- 142402 (Otro identificador: Health Canada - NOL)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre MabCampath-1h
-
Northwestern UniversityGenzyme, a Sanofi Company; Millennium Pharmaceuticals, Inc.Terminado
-
Genzyme, a Sanofi CompanyTerminadoLeucemia Linfocítica Crónica De Células BJapón
-
M.D. Anderson Cancer CenterActivo, no reclutandoLeucemia prolinfocítica de células T recurrente | Leucemia prolinfocítica de células TEstados Unidos
-
CABYCGrupo Español de Linfomas y Transplante Autólogo de Médula ÓseaTerminadoEnfermedad de injerto contra huéspedEspaña
-
University of GöttingenTerminadoLinfoma periférico de células T
-
Central Texas Neurology ConsultantsGenzyme, a Sanofi CompanyDesconocido
-
University of Illinois at ChicagoReclutamientoAnemia drepanocíticaEstados Unidos
-
Genzyme, a Sanofi CompanyBayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaTerminadoLeucemia linfocítica crónica de células B (B-CLL)Reino Unido, Bélgica, Francia, Estados Unidos, República Checa, Serbia
-
Steven E. CoutreBayerTerminadoLeucemia | Leucemia linfocítica crónica (LLC) | Leucemia cronica | Leucemia de células BEstados Unidos
-
M.D. Anderson Cancer CenterRetiradoLinfoma | Enfermedad de Hodgkin