Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015860
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-05-06
Brief Title:
STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia
Status:
COMPLETED
Status Verified Date:
2003-09
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die STI571 may stop the growth of leukemia cells Combining chemotherapy and STI571 may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of daunorubicin when combined with imatinib mesylate vincristine and prednisone in patients with lymphoid blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
Determine the safety of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the frequency of hematologic and cytogenetic responses in patients treated with this regimen
Determine the duration of response of this patient population treated with this regimen
Determine the survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of daunorubicin
Patients who have not previously received imatinib mesylate receive oral imatinib mesylate on days 1-35 Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35 All patients receive daunorubicin IV over 2-3 minutes on days 1-3 vincristine IV over 1 minute on days 1 8 15 and 22 and oral prednisone on days 1-28 Patients with more than 5 residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of daunorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the recommended phase II dose
PROJECTED ACCRUAL A maximum of 46 patients will be accrued for this study
Determine the maximum tolerated dose of daunorubicin when combined with imatinib mesylate vincristine and prednisone in patients with lymphoid blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
Determine the safety of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the frequency of hematologic and cytogenetic responses in patients treated with this regimen
Determine the duration of response of this patient population treated with this regimen
Determine the survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of daunorubicin
Patients who have not previously received imatinib mesylate receive oral imatinib mesylate on days 1-35 Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35 All patients receive daunorubicin IV over 2-3 minutes on days 1-3 vincristine IV over 1 minute on days 1 8 15 and 22 and oral prednisone on days 1-28 Patients with more than 5 residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of daunorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the recommended phase II dose
PROJECTED ACCRUAL A maximum of 46 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-4292 | None | None | None |
| UCLA-0011010 | None | None | None |
| UCLA-NCI-4292 | None | None | None |