CML-paed II

Author: Prof. Dr. Ursula Creutzig, erstellt 2007/09/19, Last modification: 2019/09/17

Title Protocol for standardised diagnostic procedures, registration, and treatment recommendations in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukaemia (CML); end of patients' recruitment: 31/10/2015; continues as registry
Disease Philadelphia chromosome-positive chronic myeloid leukaemia (CML)
Type Multicenter, non-randomized, open, prospective clinical trial
Problem / Objectives

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

Therapy / Study arms
Inclusion Criteria
  • Newly diagnosed Philadelphia-chromosome positive or BCR-ABL-positive CML
  • 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 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
Recruitment trial: 150; registry: all patients until start of following trial
Status 2007 to 31/10/2015; since 01/11/2015 as registry
Principal Investigator Prof. Dr. Meinolf Suttorp
E-Mail mailto:cml-paed@uk-erlangen.de
Contact

Investigator

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

Studienärztin

Verena Hildebrand
Universitätsklinikum Erlangen
Kinder- und Jugendklinik
Loschgestr. 15
91054 Erlangen
Telefon +49(0) 9131 85-41322
Fax +49(0) 9131 85-35742
cml-paed@uk-erlangen.de

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
91054Telefon +49(0) 9131 85-36874
Fax +49(0) 9131 85-36873
cml-paed@uk-erlangen.de

Documents
Link(s) Trial literature CML