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An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes

14 de marzo de 2016 actualizado por: Janssen-Cilag International NV

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes

The purpose of this study is to demonstrate that epoetin alfa works better than placebo in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS). The safety of epoetin alfa will also be evaluated.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a randomized (the treatment you receive will be assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled (comparison with patients that receive treatment without active ingredient), multicenter study of epoetin alfa in anemic patients who are diagnosed with myelodysplastic syndromes (MDS) according to protocol-specified criteria. This study includes a 3-week prerandomization phase, a 24-week treatment phase and a 24-week treatment extension phase. All patients enrolled in the study will complete an end-of-study visit 4 weeks after the last dose of study drug (Week 28 or Week 52), or 4 weeks after early withdrawal (unless the reason for early withdrawal is withdrawal of consent). Between 125 and 159 patients will be enrolled in the treatment phase of the study. During the screening phase, which will take place within 2 weeks before starting study drug, the study doctor will do tests to see if the patient is suitable for this study. Patients meeting entry criteria for the study will then be randomly assigned to one of the 2 treatment groups. This means that each patient who is allowed to join the study is put into a group by chance, like flipping a coin. Group 1 patients will receive epoetin alfa 450 or increased up to 1050 International Units (IU) per kg body weight administered by subcutaneous injection (injection beneath the skin) using pre-filled syringes. Injections will be done once every week at a weight-based dose regimen (the total weekly dose received will depend on your weight) with a possible total maximum dose of 40,000 IU once every week for the first 8 weeks of the treatment phase and 80,000 IU once every week at any other time during the study. Group 2 patients will receive a matching volume of placebo administered once every week by subcutaneous injection. The chance that the patient will get epoetin alfa is 2 to 1. Doses of study drug will be withheld, decreased, or increased on the basis of erythroid response, weekly hemoglobin concentrations monitored in patients and predefined dose adjustment guidelines. Patients will see the study doctor every 4 weeks for a period of 24 weeks. At each visit the patient will undergo a full hematologic evaluation, serum chemistry evaluation, measurement of blood pressure and pulse rate, recording of blood product transfusions and transfusion complications, adverse events, concomitant therapies and an evaluation for disease progression. The patient's Erythroid response will be assessed at Week 8 and every 4 weeks thereafter, until Week 24. Blinded study treatment will be administered to all patients at Week 24. However, at the end of the treatment phase (after the Week 24 response assessment), only responders will enter the double-blind treatment extension phase to measure the duration of response. Patients will continue to receive the same treatment, in the same blinded fashion, and at the same dose as received at Week 24, and will return to the study center every 4 weeks, until Week 48, for assessment of the Erythroid response and the evaluations as described above. For all non-responders at Week 24 the treatment code will be broken after Week 28 assessments. For responders at Week 48, the treatment code will be broken after the Week 48 visit, following completion of the response assessment. The treatment code will not be broken for subjects who discontinue study treatment before Week 24, irrespective of whether they are responders or nonresponders. For these subjects, the blind will not be broken until all subjects have completed the study and the database is final. Once the patient stops receiving doses of study drug, he/she will be asked to see the study doctor for the safety follow-up visit, which is scheduled 4 weeks after the last dose of study drug. Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by physical examination, laboratory tests and evaluation of adverse events. An Independent Data Monitoring Committee (IDMC) will periodically review study data and for the assessment of disease progression. The total duration of study participation will be for about 30 or 54 weeks.

Tipo de estudio

Intervencionista

Inscripción (Actual)

130

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

  • Alemania
      • Berlin, Alemania
      • Dresden, Alemania
      • Duisburg, Alemania
      • Düsseldorf, Alemania
      • Dÿsseldorf, Alemania
      • München, Alemania
      • Oldenburg, Alemania
      • Würzburg, Alemania
  • Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Federación Rusa
      • Ekaterinburg, Federación Rusa
      • St. Petersburg, Federación Rusa
  • Francia
      • Amiens, Francia
      • Angers Cedex 9, Francia
      • Bobigny, Francia
      • Colmar, Francia
      • Paris Cedex 10, Francia
      • Pessac Cedex, Francia
      • Pierre Benite Cedex, Francia
      • Saint Priest En Jarez, Francia
      • Tours Cedex 9, Francia
      • Vandoeuvre Les Nancy, Francia
  • Grecia
      • Athens, Grecia
      • Goudi-Athens, Grecia
      • Larisa, Grecia
      • Patra, Grecia
      • Thessalonikis, Grecia

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 MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening
  • Documentation of an International Prognostic Scoring System score indicating Low- or Intermediate-1-risk disease within 12 weeks prior to screening
  • Hemoglobin concentration at screening and baseline (before the first dose of study drug) of 10.0 g/dL or less
  • Screening serum erythropoietin concentration of less than 500 mU/mL
  • Red Blood Cell transfusion requirement of less than or equal to 4 red blood cell units over the last 8 weeks before randomization

Exclusion Criteria:

  • Anemia attributed to factors other than MDS (including hemolysis, chronic renal failure, hepatitis, gastrointestinal bleeding)
  • Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation therapy/exposure)
  • History of malignancy, except in situ skin basal cell carcinoma or carcinoma in situ of the cervix or breast curatively treated
  • Prior therapy with any erythropoiesis-stimulating agent (ESA) (including innovative ESAs and biosimilar ESAs for approved indications or for investigational use) in the last 8 weeks before randomization
  • Prior use of approved or experimental agents for the treatment of MDS

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: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Epoetin alfa
Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks
Droga: Group 1: Epoetin alfa
type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks
Comparador de placebos: No treatment
Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks
Droga: Group 2: Placebo
form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Erythroid response
Periodo de tiempo: at week 24
at week 24

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Maintenance of Erythroid response
Periodo de tiempo: every 4 weeks from week 24 to week 48
every 4 weeks from week 24 to week 48
Duration of response
Periodo de tiempo: every 4 weeks after week 24
every 4 weeks after week 24
Time to first Red Blood Cell transfusion
Periodo de tiempo: from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
Transfusion-free intervals
Periodo de tiempo: from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
Number of Red Blood Cell units transfused
Periodo de tiempo: from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
from baseline to study end (week 28 for non responders, week 54 for responders or 4 weeks after early withdrawal)
Quality of life as measured by Functional Assessment of Cancer Therapy-Anemia/Fatigue (FACT-An) questionnaire
Periodo de tiempo: at baseline, week 24 and week 48
at baseline, week 24 and week 48
Quality of life as measured by EuroQol 5-dimension (EQ-5D) questionnaire
Periodo de tiempo: at baseline, week 24 and week 48
at baseline, week 24 and week 48
Drug consumption
Periodo de tiempo: every 4 weeks from baseline to week 48
every 4 weeks from baseline to week 48
Duration of hospitalization
Periodo de tiempo: every 4 weeks from baseline to week 48
every 4 weeks from baseline to week 48
Number and duration of medical care encounters
Periodo de tiempo: every 4 weeks from baseline to week 48
every 4 weeks from baseline to week 48

Colaboradores e Investigadores

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

Patrocinador

Janssen-Cilag International NV

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

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 octubre de 2011

Finalización primaria (Actual)

1 de enero de 2015

Finalización del estudio (Actual)

1 de enero de 2016

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2011

Publicado por primera vez (Estimar)

27 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de marzo de 2016

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

14 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR018367
  • EPOANE3021 (Otro identificador: Janssen-Cilag International NV)
  • 2010-022884-36 (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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