Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511303
Status:
COMPLETED
Last Update Posted:
2007-08-03
First Post:
2007-08-02
Brief Title:
Protein-Tyrosine Kinase Inhibitor STI571 for Treatment of Patients With Ph Chronic Myeloid Leukemia
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Protein-Tyrosine Kinase Inhibitor STI571 for Treatment of Patients With Ph Chronic Myeloid Leukemia Who Are Resistant to or Intolerant of -Interferon A Phase II Study
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:
This is a Phase II open-label multi-center trial designed primarily to evaluate the rate of complete or major cytogenetic response of STI571 as demonstrated by a decrease in the percentage of Ph chromosome positive cells in the bone marrow in patients with CML who are refractory to or intolerant of interferon-alpha
During the core phase of the study patients will receive once daily oral administration of STI571 at a dose of 400 mg for up to 12 months After completing 12 months of therapy patients may be eligible to receive additional therapy provided that in the opinion of the investigator the patient has benefited from treatment with STI571 and in the absence of safety concerns Patients will receive STI571 on an outpatient basis
During the extended phase which is of indefinite duration patients may continue STI571 until either progression to accelerated phase blast phase death the development of intolerable toxicity or the investigator feels it is no longer in the patients best interest to continue therapy whichever comes first The number of visits will be at a reduced frequency Patients who discontinue study drug will be followed for survival for up to 5 years
STI571 will be considered active if the interferon-refractory patient population satisfies the target of achieving a complete or major response at a rate of at least 30 within the preset error limits Cytogenetic responses will be evaluated every three months and categorized as either complete 0 Ph chromosome cells or major 1 to 35 Ph chromosome cells responses STI571 will be discontinued for any patient whose disease progresses to either the accelerated phase or blast crisis
A minimum of 100 patients who are interferon refractory will receive STI571 administered at a dose of 400 mg once a day In addition the protocol is also open for patients who are intolerant to interferon-alpha in order to get a preliminary evaluation of their response to STI571 therapy Up to 100 intolerant patients will be enrolled Enrollment of intolerant patients will cease at 100 or whenever the 100 refractory patients are accrued whichever comes first
During the core phase of the study patients will receive once daily oral administration of STI571 at a dose of 400 mg for up to 12 months After completing 12 months of therapy patients may be eligible to receive additional therapy provided that in the opinion of the investigator the patient has benefited from treatment with STI571 and in the absence of safety concerns Patients will receive STI571 on an outpatient basis
During the extended phase which is of indefinite duration patients may continue STI571 until either progression to accelerated phase blast phase death the development of intolerable toxicity or the investigator feels it is no longer in the patients best interest to continue therapy whichever comes first The number of visits will be at a reduced frequency Patients who discontinue study drug will be followed for survival for up to 5 years
STI571 will be considered active if the interferon-refractory patient population satisfies the target of achieving a complete or major response at a rate of at least 30 within the preset error limits Cytogenetic responses will be evaluated every three months and categorized as either complete 0 Ph chromosome cells or major 1 to 35 Ph chromosome cells responses STI571 will be discontinued for any patient whose disease progresses to either the accelerated phase or blast crisis
A minimum of 100 patients who are interferon refractory will receive STI571 administered at a dose of 400 mg once a day In addition the protocol is also open for patients who are intolerant to interferon-alpha in order to get a preliminary evaluation of their response to STI571 therapy Up to 100 intolerant patients will be enrolled Enrollment of intolerant patients will cease at 100 or whenever the 100 refractory patients are accrued whichever comes first
Detailed Description:
This Phase II trial will evaluate at least 100 patients for the rate of complete or major cytogenetic response of STI571 as demonstrated by a decrease in the percentage of Ph chromosome positive cells in the bone marrow in patients with CML who are refractory to or intolerant of interferon-alpha Statistical considerations are based on the refractory patient population only Intolerant patients are included as long as recruitment of the refractory patients is ongoing up to a maximum of 100 intolerant patients whichever comes first
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