- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00323323
CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas
A Phase I Study of CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Rationale: The drug combination called CHOP, or Cyclophosphamide (Cytoxan), Doxorubicin (Adriamycin), Vincristine (Oncovin), and Prednisone (Deltasone), has been used against different types of lymphoma for many years. Researchers are investigating what other therapies to combine with the CHOP regimen to improve outcomes for patients with lymphoma. The current study combines CHOP with alemtuzumab, a monoclonal antibody used against leukemia. Monoclonal antibodies are a type of immunotherapy used against some types of cancer. They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. Alemtuzumab is designed to target leukemia cells that express a specific protein. The specific protein recognized by alemtuzumab is the CD52 antigen. This antigen, or substance that causes the immune system to create a specific response, is expressed on normal B and T cells, as well as on abnormal T cells characteristic of certain cancers. Alemtuzumab causes the CD52 antigen to bind with B-cell lymphocytes. This study will also assess the theory that alemtuzumab may increase the effectiveness of the chemotherapy agents included in the CHOP regimen.
Treatment: Patients in this study will receive alemtuzumab and CHOP. Alemtuzumab will be given through injections into the skin and CHOP will be administered through intravenous infusions. Patients will receive alemtuzumab alone during the first week of the study. An increasing amount of alemtuzumab will be given during the first week. If patients cannot tolerate the highest amount of alemtuzumab determined as appropriate within one week, they will be removed from the study. Once the highest dose of alemtuzumab has been achieved, patients will then receive both alemtuzumab and CHOP every three weeks. This schedule will be repeated up to eight times. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- CD-20 Negative
- Previous treatment permitted: radiation, electron beam radiotherapy, PUVA, corticosteroids, IFN, low dose methotrexate, retinoids, Ontak
- CNS disease permitted
Exclusion Criteria:
- Pregnant or Nursing
- prior Alemtuzumab
- history of active Hep C
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 |
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Experimental: Alemtuzumab/CHOP
For all patients enrolled, the study will begin with a stepped-up schedule of single agent Alemtuzumab given subcutaneously (SQ) on week #1.
Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1.
If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5. Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose
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CHOP will be given 60-120 minutes following SQ administration of Alemtuzumab as follows: cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, vincristine 1.4 mg/m2 (maximum dose = 2 mg) IV on day 1, and prednisone 100 mg PO on days 1-5.
Otros nombres:
Single agent Alemtuzumab given subcutaneously (SQ) on week #1.
Dose escalation will occur during the first week of therapy, starting with 3 mg of Alemtuzumab administered SQ on day 1.
If well tolerated, this will be followed by 10 mg SQ on day 3 and 30 mg (split into 2 injection sites) on day 5.
Otros nombres:
Plasma samples will be obtained for Alemtuzumab pharmacokinetics (PK) during the first week of single agent Alemtuzumab stepped up dosing and subsequently before and after the 5th and the 8th Alemtuzumab/CHOP dose.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Toxicity and safety of concurrent CHOP and Alemtuzumab
Periodo de tiempo: up to five years
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up to five years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Determine pharmacokinetics of Alemtuzumab
Periodo de tiempo: up to five years
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up to five years
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Determine immunosuppressive properties of Alemtuzumab + CHOP
Periodo de tiempo: up to five years
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up to five years
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Determine if Fc Receptor-gamma (FcγR) polymorphism is predictive of response or toxicity with Alemtuzumab treatment.
Periodo de tiempo: up to five years
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up to five years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Pierluigi Porcu, MD, Ohio State University
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Antibióticos, Antineoplásicos
- Ciclofosfamida
- Prednisona
- Doxorrubicina
- Vincristina
- Alemtuzumab
Otros números de identificación del estudio
- OSU-0303
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. .
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Ensayos clínicos sobre CHOP
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Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, JapanTerminadoLinfoma no HodgkinJapón
-
Sherief Abd-ElsalamReclutamiento
-
The University of Texas Health Science Center at...RetiradoLinfoma de células BEstados Unidos
-
Nanjing Yoko Biomedical Co., Ltd.ReclutamientoLinfoma difuso de células B grandes, sitio no especificadoPorcelana
-
Jiangsu HengRui Medicine Co., Ltd.Aún no reclutandoLinfoma periférico de células T
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Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); University of PennsylvaniaInscripción por invitación
-
King's College Hospital NHS TrustTerminadoLeucemia/linfoma de células T del adulto asociado al HTLV-I (ATLL)Reino Unido
-
Sun Yat-sen UniversityReclutamientoLinfoma periférico de células TPorcelana
-
Haruhiko FukudaMinistry of Health, Labour and Welfare, JapanTerminado
-
Sinocelltech Ltd.Desconocido