CML-paed II

автор:  Prof. Dr. Ursula Creutzig, erstellt am 2007/09/19, Последнее изменение:  2021/11/05

CML-paed II Protocol for standardised diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukaemia (CML)
Формы рака Philadelphia chromosome-positive chronic myeloid leukaemia (CML)
Вид исследования Multicenter, non-randomized, open, prospective clinical trial
Цель исследования

Primary objectives:- assessment of antileukaemic activity of imatinib in children and adolescents with Philadelphia chromosome-positive chronic myeloid
leukaemia

Secondary objectives:- 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

Кого берут в протокол
  • Newly diagnosed Philadelphia-chromosome positive or BCR-ABL-positive CML
  • Written informed consent
Кого не берут в протокол
  • 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 n 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
Сколько пациентов должно пройти через исследование 150
Status 2007 - 2013
Руководитель протокола Prof. Dr. Meinolf Suttorp
E-Mail cml-paed@uk-erlangen.de
С кем можно связаться

Principal Investigator

Prof. Dr. med. Markus Metzler Universitätsklinikum Erlangen Kinder- und Jugendklinik Loschgestr. 15 91054 Erlangen Telefon +49(0) 9131 85-33731 Fax +49(0) 9131 85-35742 cml-paed@uk-erlangen.de