CML-paed II

автор: Prof. Dr. Ursula Creutzig, erstellt 2007/09/19, Последнее изменение: 2015/06/11

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

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 patients with BCR-ABL-positive CML will be treated with imatinib. Serial monitoring of treatment response is performed in one month intervals during the first three months of treatment and in three months intervals thereafter. Patients with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor response) or progress of the disease while under imatinib treatment will stop imatinib and undergo stem cell transplantation. All responders to imatinib treatment with an HLA matched donor will undergo stem cell transplantation not later than 2 years after diagnosis.
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
С кем можно связаться


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

Monitoring und Documentation

Paul-Robert Binner Universitätsklinikum Erlangen Kinder- und Jugendklinik, Zentrale für klinische Studien in der Pädiatrie, Leitung: PD Dr. rer. nat. Antje Neubert Loschgestraße 15 91054 Telefon +49(0) 9131 85-36874 Fax +49(0) 9131 85-36873