Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481052
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2007-05-31
Brief Title:
Nilotinib as First-line Treatment of Ph CML in Early Chronic Phase
Sponsor:
Gruppo Italiano Malattie EMatologiche dellAdulto
Organization:
Gruppo Italiano Malattie EMatologiche dellAdulto
Study Overview
Official Title:
The Protein Tyrosine Kinase Inhibitor Nilotinib as First-line Treatment of Ph Chronic Myeloid Leucemia CML in Early Chronic Phase a Phase II Exploratory Multicenter Study GIMEMA Protocol CML 0307 EUDRACT 2007-000597-22
Status:
COMPLETED
Status Verified Date:
2022-01
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:
CML0307
Brief Summary:
Treating Ph pos CML with Imatinib is very effective since the majority of the patients achieve a complete cytogenetic response and a major molecular response and are alive and progression-free after 5 years However the great majority of responding patients are not leukemia-free and may be at risk of progression molecular cytogenetic and clinical at any time In case of disease progression due to Imatinib failure nilotinib has been found to be very effective as expected from the preclinical profile of the drug that is much more potent against BCR-ABL and inhibits nearly all the imatinib-resistant BCR-ABL mutants For these reasons nilotinib is going to be registered for the treatment of imatinib-resistant CMl patients For the same reasons nilotinib is expected to be more efficient than imatinib also front-line based on the principle that we should aim at preventing the emergence of resistance better that at treating resistance once it has emerged This expectation can be tested safely because the toxicity profile of Nilotinib may be even more convenient than that of Imatinib due to the lower frequency of edema and fluid retention
Detailed Description:
Study Phase
Phase II Prospective multicentric non randomized open label
Objectives
The primary objective of the trial is to investigate the cytogenetic and molecular effects of the protein tyrosine kinase PTK inhibitor nilotinib in the treatment of early chronic phase Ph CML
The secondary objectives are
To investigate in early CP Ph CML patients treated with nilotinib the clinical and the hematologic effects the effect on bcrabl point mutations the kinetic of the response the toxicity the compliance to treatment and the dose density
Study design
This study is an open-label multicenter exploratory Phase II study of nilotinib administered orally twice daily for one year For the patients who will benefit an extension to 4 years is planned
Visit Schedule and Assessments
A visit with blood counts and differential and serum chemistry is due baseline every 15 days for 3 months hence every 30 days
An ECG is due baseline after 15 and 30 days hence at 60 90 150 240 and 360 days
An echocardiogram is due baseline and at end-of-study 360 days or early withdrawal
A bone marrow aspirate is due baseline cytology cytogenetics and quantitative molecular biology after 3 and 6 months cytology and cytogenetics and after 12 months cytology cytogenetics quantitative molecular biology and mutational analysis
A peripheral blood sample is due baseline at 30 60 90 180 270 and 360 days for quantitative molecular biology
After the end of the study ie after one year clinical cytogenetic and molecular data are due every 6 months
Biologic Monitoring
Bone marrow and peripheral blood cells will be collected before during and at the end of the study stored at the central lab in Bologna and used for molecular assays that are listed in details in the protocol with the exclusion of any test allowing the identification of patients genotype The samples are kept for a minimum of 10 years and can be destroyed upon patient request A specific consent form to the sample storage will be submitted to the patients
Phase II Prospective multicentric non randomized open label
Objectives
The primary objective of the trial is to investigate the cytogenetic and molecular effects of the protein tyrosine kinase PTK inhibitor nilotinib in the treatment of early chronic phase Ph CML
The secondary objectives are
To investigate in early CP Ph CML patients treated with nilotinib the clinical and the hematologic effects the effect on bcrabl point mutations the kinetic of the response the toxicity the compliance to treatment and the dose density
Study design
This study is an open-label multicenter exploratory Phase II study of nilotinib administered orally twice daily for one year For the patients who will benefit an extension to 4 years is planned
Visit Schedule and Assessments
A visit with blood counts and differential and serum chemistry is due baseline every 15 days for 3 months hence every 30 days
An ECG is due baseline after 15 and 30 days hence at 60 90 150 240 and 360 days
An echocardiogram is due baseline and at end-of-study 360 days or early withdrawal
A bone marrow aspirate is due baseline cytology cytogenetics and quantitative molecular biology after 3 and 6 months cytology and cytogenetics and after 12 months cytology cytogenetics quantitative molecular biology and mutational analysis
A peripheral blood sample is due baseline at 30 60 90 180 270 and 360 days for quantitative molecular biology
After the end of the study ie after one year clinical cytogenetic and molecular data are due every 6 months
Biologic Monitoring
Bone marrow and peripheral blood cells will be collected before during and at the end of the study stored at the central lab in Bologna and used for molecular assays that are listed in details in the protocol with the exclusion of any test allowing the identification of patients genotype The samples are kept for a minimum of 10 years and can be destroyed upon patient request A specific consent form to the sample storage will be submitted to the patients
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