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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)

4 de octubre de 2016 actualizado por: Novartis Pharmaceuticals

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.

The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

207

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1221ADH
        • Novartis Investigative Site
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
        • Novartis Investigative Site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novartis Investigative Site
      • South Brisbane, Queensland, Australia, 4101
        • Novartis Investigative Site
      • Woolloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Novartis Investigative Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Novartis Investigative Site
      • Prahran, Victoria, Australia, 3181
        • Novartis Investigative Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Novartis Investigative Site
    • MG
      • Belo Horizonte, MG, Brasil, 30130-100
        • Novartis Investigative Site
    • PR
      • Curitiba, PR, Brasil, 80060-900
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brasil, 21941-913
        • Novartis Investigative Site
    • SP
      • Campinas, SP, Brasil, 13083-970
        • Novartis Investigative Site
      • Sao Paulo, SP, Brasil, 05403-000
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canadá, L8H 4J9
        • Novartis Investigative Site
      • Toronto, Ontario, Canadá, M5G 2M9
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canadá, H1T 2M4
        • Novartis Investigative Site
      • Québec, Quebec, Canadá, G1J 1Z4
        • Novartis Investigative Site
      • Madrid, España, 28006
        • Novartis Investigative Site
      • Madrid, España, 28007
        • Novartis Investigative Site
    • Andalucia
      • Malaga, Andalucia, España, 29010
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, España, 08036
        • Novartis Investigative Site
    • Navarra
      • Pamplona, Navarra, España, 31008
        • Novartis Investigative Site
      • Bordeaux, Francia, 33076
        • Novartis Investigative Site
      • Creteil, Francia, 94010
        • Novartis Investigative Site
      • Lyon cedex 04, Francia, 69317
        • Novartis Investigative Site
      • Paris, Francia, 75010
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, Francia, 54511
        • Novartis Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Nilotinib
Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months.
Supplied in 200 mg capsules
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.
Supplied in 100 mg and 400 mg capsules
Otros nombres:
  • Glivec/Glivec

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of Confirmed Best Cumulative Complete Molecular Response (CMR)
Periodo de tiempo: 12 months
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.
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of Confirmed Best Cumulative CMR
Periodo de tiempo: 24 months, 36 month, 48 months
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.
24 months, 36 month, 48 months
Number of Cross-over Participants With CMR
Periodo de tiempo: 24 months, 36 months, 48 months
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.
24 months, 36 months, 48 months
Progression Free Survival (PFS)
Periodo de tiempo: 48 months
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.
48 months
Event-free Survival
Periodo de tiempo: 48 months
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.
48 months
Overall Survival
Periodo de tiempo: 48 months
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.
48 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2009

Finalización primaria (Actual)

1 de julio de 2015

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

25 de septiembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

25 de septiembre de 2008

Publicado por primera vez (Estimar)

26 de septiembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de noviembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

4 de octubre de 2016

Última verificación

1 de octubre de 2016

Más información

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 Nilotinib

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