Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006343
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2000-10-04
Brief Title:
STI571 Compared With Interferon Alfa Plus Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Phase III Study of STI571 Versus Interferon-a IFN-a Combined With Cytarabine Ara-C in Patients With Newly Diagnosed Previously Untreated Philadelphia Chromosome Positive Ph Chronic Myelogenous Leukemia in Chronic Phase CML-CP
Status:
COMPLETED
Status Verified Date:
2012-12
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:
RATIONALE Biological therapies such as interferon-alfa and STI571 may interfere with the growth of cancer cells It is not yet known if STI571 is more effective than interferon alfa plus cytarabine for chronic myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of STI571 with that of interferon alfa plus cytarabine in treating patients who have newly diagnosed chronic myelogenous leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of STI571 with that of interferon alfa plus cytarabine in treating patients who have newly diagnosed chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Compare the time to treatment failure and overall survival in patients with newly diagnosed previously untreated Philadelphia chromosome positive chronic phase chronic myelogenous leukemia treated with STI571 vs interferon alfa combined with cytarabine II Compare the quality of life and disease and treatment related toxicities in patients treated with these 2 regimens III Compare the rate and duration of complete hematologic response CHR and major cytogenetic response MCR in patients treated with these 2 regimens IV Compare the rate and duration of MCR and CHR attributable to crossover therapy in patients who crossover to receive STI571 OR interferon alfa combined with cytarabine V Compare the tolerability and safety of these regimens in these patients VI Determine the population pharmacokinetics of STI571 in these patients
OUTLINE This is a randomized open label crossover multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive oral STI571 once daily Arm II Patients receive interferon alfa IFN-A subcutaneously SQ daily Gradual intrapatient dose escalation is performed until the target dose of IFN-A is achieved Patients then also receive cytarabine SQ daily for 10 days every month Cytarabine is discontinued when a complete cytogenetic response is achieved and confirmed on two consecutive occasions not more than 3 months apart Both arms Courses repeat monthly in the absence of progression to accelerated phase or blast crisis or unacceptable toxicity Patients with no complete hematologic response at 6 months no major cytogenetic response at year 2 or loss of complete hematologic response without progression to accelerated or blastic phase discontinue treatment on the arm to which they were originally randomized and begin treatment on the other arm Crossover courses repeat monthly in the absence of progression to accelerated phase or blast crisis or unacceptable toxicity Quality of life is assessed prior to study monthly for the first 6 months of study at 9 12 18 and 24 months at time of crossover if applicable and at treatment discontinuation before year 2 if applicable All patients are followed every 3 months for up to 8 years
PROJECTED ACCRUAL A total of 850 patients 425 per arm will be accrued for this study
OUTLINE This is a randomized open label crossover multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive oral STI571 once daily Arm II Patients receive interferon alfa IFN-A subcutaneously SQ daily Gradual intrapatient dose escalation is performed until the target dose of IFN-A is achieved Patients then also receive cytarabine SQ daily for 10 days every month Cytarabine is discontinued when a complete cytogenetic response is achieved and confirmed on two consecutive occasions not more than 3 months apart Both arms Courses repeat monthly in the absence of progression to accelerated phase or blast crisis or unacceptable toxicity Patients with no complete hematologic response at 6 months no major cytogenetic response at year 2 or loss of complete hematologic response without progression to accelerated or blastic phase discontinue treatment on the arm to which they were originally randomized and begin treatment on the other arm Crossover courses repeat monthly in the absence of progression to accelerated phase or blast crisis or unacceptable toxicity Quality of life is assessed prior to study monthly for the first 6 months of study at 9 12 18 and 24 months at time of crossover if applicable and at treatment discontinuation before year 2 if applicable All patients are followed every 3 months for up to 8 years
PROJECTED ACCRUAL A total of 850 patients 425 per arm will be accrued for this study
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 |
|---|---|---|---|
| FHCRC-155600 | None | None | None |
| NOVARTIS-CSTI5710106 | None | None | None |