Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445822
Status:
UNKNOWN
Last Update Posted:
2012-02-29
First Post:
2007-03-08
Brief Title:
Registration of Children With CML and Treatment With Imatinib
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
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:
UNKNOWN
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:
Newly diagnosed pediatric patients age 19 years 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
Detailed Description:
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
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2007-001339-69 | None | None | None |