Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510926
Status:
COMPLETED
Last Update Posted:
2007-08-03
First Post:
2007-08-02
Brief Title:
Exploratory Study of IMATINIB High Dose in Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
CML021 A Phase II Exploratory Study of IMATINIB High Dose 800mggg in the Treatment of Newly Diagnosed Intermediate Risk Chronic Myeloid Leukemia in Chronic Phase
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
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:
None
Brief Summary:
Results in CP are better in patients treated early after the onset of the disease with respect to late CP To date the early McR rate to imatinib is clearly higher in low and intermediate risk versus high risk 88 and 84 versus 65 High dose of imatinib as shown in phase I-III trials may offer the possibility to increase the response rate of patients belonging to this risk category
Detailed Description:
This is a phase II multicenter open-label study designed to investigate the efficacy hematological response cytogenetic response and molecular response and feasibility tolerance compliance and safety of the tyrosine kinase inhibitor imatinib mesylate formerly STI 571 GLIVECÔ Novartis Pharma at high dose 800 mgdaily serial number protocol ICSGCML021 in patients with Ph chronic myeloid leukemia CML in chronic phase CP previously untreated at intermediate Sokal risk
With aIFN responses HR and CgR are significantly influenced by the disease phase and in CP patients by risk aIFN induces rare and short lived HR and CgR any degree in late CP and particularly in accelerated and blastic phase
Moreover in CP patients Sokals risk influences significantly the probability of obtaining a MCgR after aIfaIFN As far as survival after aIFN even in CCgR patients the long term survival is signifcantly influenced by risk The European investigators on Interferon in CML EICML collected informations on response and survival on 317 complete cytogenetic responders to IFN The 10 years survival of the whole patients population was 75 but after stratification by risk a significant difference in 10 years survival rates was found in favour of low risk patients 89 if compared with intermediate risk 70 and high risk patients 54 low vs high risk p 00001 intermediate vs high p 0003 log-rank test
Long term survival data still lacks after imatinib However it has been already shown that the disease phase influences the efficacy of imatinib in CML responses HR and particularly CgR are better in CP versus accelerated and blastic phase Results in CP are better in patients treated early after the onset of the disease with respect to late CP To date the early McR rate to imatinib is clearly higher in low and intermediate risk versus high risk 88 and 84 versus 65
Two scoring systems are available for disease risk evaluation Sokal and Euro Sokal risk is based on chemotherapy treated patients and Euro risk is based on aIFN trated patients it is not known to date if one or both of the scoring systems will apply to imatinib treated patients Moreover the Sokal system has been applied to stratify the patients by risk in all the large clinical trials of imatinib in CML in the last 3 years and consequently Sokal score will be employed in the present trial
Study objectives
Primary
To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated intermediate Sokal risk CML treated with imatinib 800 mgdaily
Secondary
To determine
1 The rate of major cytogenetic response at 6 and 12 months
2 The kinetic of cytogenetic response at 6 and 12 months
3 The duration of complete cytogenetic response
4 The rate and duration of hematologic response
5 The degree and the timing of molecular response
6 The time to accelerated and blast crisis and overall survival
7 The safety and tolerability of the treatment
With aIFN responses HR and CgR are significantly influenced by the disease phase and in CP patients by risk aIFN induces rare and short lived HR and CgR any degree in late CP and particularly in accelerated and blastic phase
Moreover in CP patients Sokals risk influences significantly the probability of obtaining a MCgR after aIfaIFN As far as survival after aIFN even in CCgR patients the long term survival is signifcantly influenced by risk The European investigators on Interferon in CML EICML collected informations on response and survival on 317 complete cytogenetic responders to IFN The 10 years survival of the whole patients population was 75 but after stratification by risk a significant difference in 10 years survival rates was found in favour of low risk patients 89 if compared with intermediate risk 70 and high risk patients 54 low vs high risk p 00001 intermediate vs high p 0003 log-rank test
Long term survival data still lacks after imatinib However it has been already shown that the disease phase influences the efficacy of imatinib in CML responses HR and particularly CgR are better in CP versus accelerated and blastic phase Results in CP are better in patients treated early after the onset of the disease with respect to late CP To date the early McR rate to imatinib is clearly higher in low and intermediate risk versus high risk 88 and 84 versus 65
Two scoring systems are available for disease risk evaluation Sokal and Euro Sokal risk is based on chemotherapy treated patients and Euro risk is based on aIFN trated patients it is not known to date if one or both of the scoring systems will apply to imatinib treated patients Moreover the Sokal system has been applied to stratify the patients by risk in all the large clinical trials of imatinib in CML in the last 3 years and consequently Sokal score will be employed in the present trial
Study objectives
Primary
To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated intermediate Sokal risk CML treated with imatinib 800 mgdaily
Secondary
To determine
1 The rate of major cytogenetic response at 6 and 12 months
2 The kinetic of cytogenetic response at 6 and 12 months
3 The duration of complete cytogenetic response
4 The rate and duration of hematologic response
5 The degree and the timing of molecular response
6 The time to accelerated and blast crisis and overall survival
7 The safety and tolerability of the treatment
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