Registration of Children With CML and Treatment With Imatinib (CML-paed II)

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