Ignite Creation Date:
2025-12-18 @ 9:58 AM
Ignite Modification Date:
2025-12-18 @ 9:58 AM
Study NCT ID:
NCT00445822
Status:
None
Last Update Posted:
2012-02-29 00:00:00
First Post:
2007-03-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registration of Children With CML and Treatment With Imatinib
Sponsor:
None
Organization:
Study Overview
Official Title:
Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
Status:
None
Status Verified Date:
2012-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CML-paed II
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: