- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01700751
Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation
A Pilot Study of Brentuximab Vedotin in the Prevention of Graft-Versus-Host Disease (GVHD) After Unrelated Allogeneic Stem Cell Transplantation
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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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:
Patient must be scheduled to undergo stem cell transplantation for one of the following diagnoses:
- acute myeloid leukemia (AML) in CR1 (first complete remission, CR or CRi) or CR2 (second complete remission, CR or CRi),
- acute lymphoblastic leukemia (ALL) in CR1 or CR2 (CR or CRi)
- myelodysplastic syndrome (MDS) without progression to AML.
- Chronic myelogenous leukemia (CML)
- Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD)
- Chronic lymphocytic leukemia (CLL)
- Multiple myeloma (MM)
- Patients must be the recipient of unrelated donor peripheral blood stem cell products. Mismatches at both antigen and allele level will be eligible. Match must be 6 or 7 out of 8 loci (HLA A, B, C, and DRB1).
- Patient must receive any one of the following conditioning regimens: total body radiation (single or fractionated dose)/cyclophosphamide, busulfan/ cyclophosphamide, or fludarabine/busulfan/lymphocyte immune globulin (ATGAM/thymo).
- Patient must be ≥ 18 years and ≤ 70 years of age.
- Patient must have an ECOG performance status ≤ 2 or Karnofsky performance scale ≥ 60%
- Patient must have CD34+ stem cells ≥ 2x106/kg (actual body weight of the recipient) available for transplantation.
Patient must have appropriate organ function as defined below (this criterion should be met on screening and on the day of the first dose of brentuximab vedotin (as assessed prior to dosing)):
- Total bilirubin ≤ 2.0 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Serum creatinine ≤ 2.0 x IULN
- Estimated Creatinine Clearance > 30 ml/min
- Cardiac ejection fraction > 40%
- DLCO/VA > 40%
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patient must be able to understand and willing to sign an IRB approved written informed consent document.
Exclusion Criteria:
- Patient must not have had prior exposure to brentuximab vedotin.
- Patient must not have a history of other malignancy that has not been in remission for at least 3 years, with the exception of basal non-melanoma skin cancer which were treated with local resection only or intraepithelial lesions or carcinoma in situ of the cervix or prostate that has been curatively treated.
- Patient must not be receiving any other investigational agents.
- Patient must not have active CNS involvement.
- Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to brentuximab vedotin or other agents used in the study.
- Patients must not have had previous radiation therapy to the mediastinum or lungs.
- Patient must not have an uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active pulmonary diseases, or psychiatric illness/social situations that would limit compliance with study requirements (this criterion should be met on screening and on the day of but prior to first dose of brentuximab vedotin).
- Patient must not be pregnant and/or breastfeeding.
- Patient must not be known to be HIV-positive on combination antiretroviral therapies.
- Patient must not have had a previous allogeneic or syngeneic transplant. Prior autologous transplant is allowed.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- 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: Dose Level 0 (starting dose)
brentuximab vedotin 0.3mg/kg, given IV on Days 7, 28, 49 & 70
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Otros nombres:
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Experimental: Dose Level 1
brentuximab vedotin 0.6mg/kg, given IV on Days 7, 28, 49 & 70
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Otros nombres:
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Experimental: Dose Level 2
brentuximab vedotin 1.2mg/kg, given IV on Days 7, 28, 49 & 70
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Otros nombres:
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Experimental: Dose Level 3
brentuximab vedotin 1.8mg/kg, given IV on Days 7, 28, 49 & 70
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Otros nombres:
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Sin intervención: Control Dose Level
The first 3 patients will not receive brentuximab vedotin.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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MTD of brentuximab vedotin when administered with a GVHD prophylaxis regimen
Periodo de tiempo: 37 days
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Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity; Hematologic DLT is defined as ANC < 500/mm3 for three consecutive days beyond Day +21 that was determined by the investigator to be likely related to brentuximab vedotin. Non-hematologic DLT is defined as any grade 3 or higher non-hematologic toxicity that was determined by the investigator to be possibly, probably, or definitely related to brentuximab vedotin, with the following specific exceptions:
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37 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Safety and tolerability of brentuximab vedotin when administered with a GVHD prophylaxis regimen
Periodo de tiempo: 100 days
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Toxicities described and graded using CTCAE version 4.0; described by patient, type, and grade for each dose level; summarized by counts and percentage of patients in the corresponding categories
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100 days
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Rate of acute GVHD
Periodo de tiempo: 100 days
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Proportion of all subjects who experience symptoms consistent with grade 2-4 acute GVHD; using the standard grading system adapted from the Glucksberg clinical stage and grade of acute GVHD
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100 days
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Rate of chronic GVHD
Periodo de tiempo: 2 years
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Proportion of all subjects who experience symptoms consistent with chronic GVHD; assessment will begin after Day 100 using the NIH consensus criteria for diagnosis and staging of chronic GVHD
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2 years
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Progression-free survival
Periodo de tiempo: 2 years
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Duration from the time of transplant to time of first progression, death, relapse after complete response, or the date the patient was last known to be in remission; estimated with Kaplan-Meier methods.
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2 years
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Overall survival.
Periodo de tiempo: 2 years
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Duration from the time of transplant to death or last follow-up; estimated with Kaplan-Meier methods.
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2 years
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1-year non-relapse mortality rate
Periodo de tiempo: 1 year
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Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.
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1 year
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2-year non-relapse mortality rate
Periodo de tiempo: 2 years
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Defined as the percentage of patients dying from etiologies other than disease relapse; estimated with Kaplan-Meier methods.
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2 years
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1-year disease relapse rate
Periodo de tiempo: 1 year
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Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.
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1 year
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2-year disease relapse rate
Periodo de tiempo: 2 years
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Defined as the percentage of patients who have disease relapse; estimated with Kaplan-Meier methods.
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2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Enfermedades de la médula ósea
- Enfermedades hematológicas
- Leucemia Linfoide
- Leucemia Mieloide
- Síndromes mielodisplásicos
- Leucemia
- Leucemia Mieloide Aguda
- Leucemia-linfoma linfoblástico de células precursoras
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Brentuximab vedotina
Otros números de identificación del estudio
- 201211047
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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 brentuximab vedotin
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Fondazione Italiana Linfomi ONLUSTerminadoLinfoma de Hodgkin en recaída/refractarioItalia
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Shanghai Zhongshan HospitalTakeda; BeiGeneAún no reclutandoNúmeros de linfoma de células NK/T
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Grupo Español de Linfomas y Transplante Autólogo...ReclutamientoLinfoma de Hodgkin en adultosEspaña
-
TakedaTerminadoLinfoma de Hodgkin CD30+ en recaída o refractario o linfoma anaplásico de células grandesJapón
-
TakedaTerminadoLinfoma periférico de células T | Linfoma de Hodgkin pediátricoJapón
-
The Lymphoma Academic Research OrganisationTerminadoLinfoma de células T periférico refractario | Linfoma periférico de células T en recaídaFrancia, Bélgica
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The First Affiliated Hospital with Nanjing Medical...First Affiliated Hospital of Wenzhou Medical UniversityReclutamiento
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Wuhan Union Hospital, ChinaReclutamientoCáncer de mama | Terapia neoadyuvantePorcelana
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Tianjin Medical University Cancer Institute and...Aún no reclutando
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The First Affiliated Hospital with Nanjing Medical...Terminado