CML-paed II

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

CML-paed II 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

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.

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 cml-paed@uk-erlangen.de
Contact

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

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

Link(s) Trial literature CML