- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00760877
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1221ADH
- Novartis Investigative Site
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New South Wales
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St. Leonards, New South Wales, Australia, 2065
- Novartis Investigative Site
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Westmead, New South Wales, Australia, 2145
- Novartis Investigative Site
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Queensland
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Herston, Queensland, Australia, 4029
- Novartis Investigative Site
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South Brisbane, Queensland, Australia, 4101
- Novartis Investigative Site
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Woolloongabba, Queensland, Australia, 4102
- Novartis Investigative Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- Novartis Investigative Site
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Victoria
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Parkville, Victoria, Australia, 3050
- Novartis Investigative Site
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Prahran, Victoria, Australia, 3181
- Novartis Investigative Site
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Novartis Investigative Site
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MG
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Belo Horizonte, MG, Brasil, 30130-100
- Novartis Investigative Site
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PR
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Curitiba, PR, Brasil, 80060-900
- Novartis Investigative Site
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RJ
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Rio de Janeiro, RJ, Brasil, 21941-913
- Novartis Investigative Site
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SP
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Campinas, SP, Brasil, 13083-970
- Novartis Investigative Site
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Sao Paulo, SP, Brasil, 05403-000
- Novartis Investigative Site
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Novartis Investigative Site
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Ontario
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Hamilton, Ontario, Canadá, L8H 4J9
- Novartis Investigative Site
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Toronto, Ontario, Canadá, M5G 2M9
- Novartis Investigative Site
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Quebec
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Montreal, Quebec, Canadá, H1T 2M4
- Novartis Investigative Site
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Québec, Quebec, Canadá, G1J 1Z4
- Novartis Investigative Site
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Madrid, España, 28006
- Novartis Investigative Site
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Madrid, España, 28007
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, España, 29010
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, España, 08036
- Novartis Investigative Site
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Navarra
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Pamplona, Navarra, España, 31008
- Novartis Investigative Site
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Bordeaux, Francia, 33076
- Novartis Investigative Site
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Creteil, Francia, 94010
- Novartis Investigative Site
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Lyon cedex 04, Francia, 69317
- Novartis Investigative Site
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Paris, Francia, 75010
- Novartis Investigative Site
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Vandoeuvre les Nancy, Francia, 54511
- Novartis Investigative Site
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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:
Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease demonstrated by two PCR positive tests 3 months apart both during the past 6 months.
Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No other current or planned anti-leukemia therapies
Exclusion Criteria:
Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months) Patient has received another investigational agent within last 6 months or tyrosine kinase inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation
Impaired cardiac function including any one of the following:
Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc Myocardial infarction within 12 months prior to starting study Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension) History of or presence of clinically significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Nilotinib
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
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Supplied in 200 mg capsules
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Comparador activo: Imatinib
Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
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Supplied in 100 mg and 400 mg capsules
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)
Periodo de tiempo: 12 months
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The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the first 12 months of treatment after the randomization date.
Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders.
Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders.
The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by real-time quantitative polymerase chain reaction (RQ-PCR) where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Rate of Confirmed Best Cumulative CMR
Periodo de tiempo: 24 months, 36 month, 48 months
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The rate of confirmed best cumulative CMR was defined as the number of participants who had confirmed CMR during the 24, 36 and 48 months post treatment after the randomization date.
Participants who achieved confirmed best cumulative CMR during the first 12 months were considered responders.
Participants who dropped out early or who did not provide sufficient data for any reason were considered to be non-responders.
The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
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24 months, 36 month, 48 months
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Number of Cross-over Participants With CMR
Periodo de tiempo: 24 months, 36 months, 48 months
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The definition of CMR is undetectable BCR-ABL (fusion gene formed between bcr gene from chromosome 22 and abl gene from chromosome 9) where BCR-ABL ratio in % international scale (IS) ≤ 0.00001 by RQ-PCR where there was no detectable BCR-ABL and 1) the test had a sensitivity of at least 4.5 logs below the standardized baseline; 2) RQ-PCR negativity was confirmed on the next RQ-PCR sample (usually 3 months later); and 3) the date of confirmed CMR was the date of the first of two negative results with sensitivity >4.5 logs.
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24 months, 36 months, 48 months
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Progression Free Survival (PFS)
Periodo de tiempo: 48 months
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PFS was defined as the time from the date of randomization to the date of the earliest documented progression-defining event as follows: transformation to blast crisis or accelerated phase disease, or death from any cause.
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48 months
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Event-free Survival
Periodo de tiempo: 48 months
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Event-free survival was defined as the time from the date of randomization to the date of first occurrence of any of the following events on study treatment: loss of complete hematological response, confirmed loss of complete cytogenetic response (CCyR), confirmed loss of major molecular response (MMR), death from any cause during treatment, progression to the accelerated phase or blast crisis of chronic myelogenous leukemia (CML) per European Leukemia Network (ELN) criteria, whichever was earliest.
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48 months
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Overall Survival
Periodo de tiempo: 48 months
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Overall survival was defined as the time from the date of randomization to the date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
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48 months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y 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
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades de la médula ósea
- Enfermedades hematológicas
- Trastornos mieloproliferativos
- Leucemia
- Leucemia Mieloide
- Leucemia, Mielógena, Crónica, BCR-ABL Positivo
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Inhibidores de la proteína quinasa
- Mesilato de imatinib
Otros números de identificación del estudio
- CAMN107A2405
- 2009-012616-40 (Número EudraCT)
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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