- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00445822
Registration of Children With CML and Treatment With Imatinib (CML-paed II)
Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Indication:
Newly diagnosed pediatric patients with bcr-abl-positive CML.
Design:
Multicenter, non-randomized, open, prospective clinical trial.
Objectives:
Primary:
- assessment of antileukemic activity of imatinib in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia
Secondary:
- assessment of the time-to event-efficacy variables
- correlation of the quality of haematological, cytogenetical and molecular remission in children and adolescents with CML on ongoing imatinib therapy with survival
- safety of imatinib
Endpoints:
Primary:
- rate of haematological, cytogenetical and molecular remissions
Secondary:
- time to progression
- duration of chronic phase
- time to loss of response
- overall survival
- assessment of treatment-related toxicities in children and adolescents.
Inclusion criteria:
Newly diagnosed Ph+ or bcr-abl-positive CML- Male and female patients aged 0 to 18 years- Written informed consent
Exclusion criteria:
- CML without bcr-abl rearrangement detectable by PCR
- Pretreatment with Interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of CML). However, these patients may be registered as observational patients.
- Any other severe underlying disease beside CML.
- Age > 18 years
- Pregnant or lactating women
- Subjects unlikely to comply with the requirements of the protocol
Number of patients to be enrolled: 150
Recruitment period: 5 years
Treatment period: 2 years
Planned start of study: 2007
Planned end of study: 2013
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Meinolf Suttorp, Prof. Dr.
- Número de teléfono: 3522 +49 351 458
- Correo electrónico: meinolf.suttorp@uniklinikum-dresden.de
Copia de seguridad de contactos de estudio
- Nombre: Xenia Graehlert, Dr.
- Número de teléfono: 5160 +49 351 458
- Correo electrónico: grahlert@uniklinikum-dresden.de
Ubicaciones de estudio
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Saxonia
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Dresden, Saxonia, Alemania, D-01307
- Reclutamiento
- University Children's Hopsital, Technical University of Dresden, Fetscherstr. 74
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Contacto:
- Meinolf Suttorp, Prof. Dr.
- Número de teléfono: 3522 +49 351 458
- Correo electrónico: meinolf.suttorp@uniklinikum-dresden.de
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Newly diagnosed Ph+ or bcr-abl-positive CML
- Male and female patients aged 0 to 18 years
- Written informed consent
Exclusion Criteria:
- CML without bcr-abl rearrangement detectable by PCR
- Pretreatment with Interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of CML). However, these patients may be registered as observational patients.
- Any other severe underlying disease beside CML.
- Age > 18 years- Pregnant or lactating women
- Subjects unlikely to comply with the requirements of the protocol
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Meinolf Suttorp, Prof. Dr., University Children's Hospital, Dpt. Ped. Hemato-Oncology, Technical University of Dresden, Germany
Publicaciones y enlaces útiles
Publicaciones Generales
- Millot F, Guilhot J, Nelken B, Leblanc T, De Bont ES, Bekassy AN, Gadner H, Sufliarska S, Stary J, Gschaidmeier H, Guilhot F, Suttorp M. Imatinib mesylate is effective in children with chronic myelogenous leukemia in late chronic and advanced phase and in relapse after stem cell transplantation. Leukemia. 2006 Feb;20(2):187-92. doi: 10.1038/sj.leu.2404051.
- Adler R, Viehmann S, Kuhlisch E, Martiniak Y, Rottgers S, Harbott J, Suttorp M. Correlation of BCR/ABL transcript variants with patients' characteristics in childhood chronic myeloid leukaemia. Eur J Haematol. 2009 Feb;82(2):112-8. doi: 10.1111/j.1600-0609.2008.01170.x. Epub 2008 Nov 10.
- Suttorp M. Innovative approaches of targeted therapy for CML of childhood in combination with paediatric haematopoietic SCT. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S40-6. doi: 10.1038/bmt.2008.282.
- Schmid H, Jaeger BA, Lohse J, Suttorp M. Longitudinal growth retardation in a prepuberal girl with chronic myeloid leukemia on long-term treatment with imatinib. Haematologica. 2009 Aug;94(8):1177-9. doi: 10.3324/haematol.2009.008359. Epub 2009 Jun 22. No abstract available.
- Bacher U, Klyuchnikov E, Zabelina T, Ottinger H, Beelen DW, Schrezenmeier H, Ehninger G, Muller C, Berger J, Suttorp M, Kolb HJ, Kroger N, Zander AR. The changing scene of allogeneic stem cell transplantation for chronic myeloid leukemia--a report from the German Registry covering the period from 1998 to 2004. Ann Hematol. 2009 Dec;88(12):1237-47. doi: 10.1007/s00277-009-0737-3. Epub 2009 Mar 25.
- Suttorp M, Millot F. Treatment of pediatric chronic myeloid leukemia in the year 2010: use of tyrosine kinase inhibitors and stem-cell transplantation. Hematology Am Soc Hematol Educ Program. 2010;2010:368-76. doi: 10.1182/asheducation-2010.1.368.
- Suttorp M, Yaniv I, Schultz KR. Controversies in the treatment of CML in children and adolescents: TKIs versus BMT? Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S115-22. doi: 10.1016/j.bbmt.2010.09.003.
- Suttorp M, Claviez A, Bader P, Peters C, Gadner H, Ebell W, Dilloo D, Kremens B, Kabisch H, Fuhrer M, Zintl F, Gobel U, Klingebiel T. Allogeneic stem cell transplantation for pediatric and adolescent patients with CML: results from the prospective trial CML-paed I. Klin Padiatr. 2009 Nov-Dec;221(6):351-7. doi: 10.1055/s-0029-1239529. Epub 2009 Nov 4.
- Suttorp M, Tauer JT, Millot F: Chronic myeloid leukemia in children: diagnostics and management Onkologie (CZ) 5(2):12-15, 2011
- Suttorp M, Thiede C, Tauer JT, Range U, Schlegelberger B, von Neuhoff N. Impact of the type of the BCR-ABL fusion transcript on the molecular response in pediatric patients with chronic myeloid leukemia. Haematologica. 2010 May;95(5):852-3. doi: 10.3324/haematol.2009.019224. Epub 2010 Feb 9. No abstract available.
- Knofler R, Lange BS, Paul F, Tiebel O, Suttorp M. Bleeding signs due to acquired von Willebrand syndrome at diagnosis of chronic myeloid leukaemia in children. Br J Haematol. 2020 Mar;188(5):701-706. doi: 10.1111/bjh.16241. Epub 2019 Oct 15.
- Ulmer A, Tabea Tauer J, Glauche I, Jung R, Suttorp M. TK inhibitor treatment disrupts growth hormone axis: clinical observations in children with CML and experimental data from a juvenile animal model. Klin Padiatr. 2013 May;225(3):120-6. doi: 10.1055/s-0033-1343483. Epub 2013 May 28.
- Jaeger BA, Tauer JT, Ulmer A, Kuhlisch E, Roth HJ, Suttorp M. Changes in bone metabolic parameters in children with chronic myeloid leukemia on imatinib treatment. Med Sci Monit. 2012 Dec;18(12):CR721-8. doi: 10.12659/msm.883599.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TUD-CML-paed 016
- EudraCT: 2007-001339-69
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