Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258271
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
2005-11-22
Brief Title:
Cladribine Cytarabine and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Phase I Study of CLAG Regimen in Combination With Imatinib Mesylate Gleevec in Refractory or Relapsed Leukemias
Status:
COMPLETED
Status Verified Date:
2013-10
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 such as cladribine and cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving cladribine and cytarabine together with imatinib mesylate may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia
PURPOSE This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of cladribine cytarabine and imatinib mesylate in patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia
Determine the maximum tolerated dose of imatinib mesylate in patients treated with this regimen
Correlate the expression of c-kit and the presence of c-kit mutations with clinical response in patients treated with this regimen
Correlate the in vitro inhibitory effects of imatinib mesylate and cytarabine on the proliferation and survival of leukemic cells with clinical response in patients treated with this regimen
OUTLINE This is a dose-escalation study of imatinib mesylate
Patients receive oral imatinib mesylate once daily on days 1-15 and cladribine IV over 2 hours and cytarabine IV over 4 hours on days 3-7 Patients also receive filgrastim G-CSF subcutaneously on days 2-7 Treatment repeats every 15 days for 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed periodically for up to 1 year
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for this study
Determine the safety and feasibility of cladribine cytarabine and imatinib mesylate in patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia
Determine the maximum tolerated dose of imatinib mesylate in patients treated with this regimen
Correlate the expression of c-kit and the presence of c-kit mutations with clinical response in patients treated with this regimen
Correlate the in vitro inhibitory effects of imatinib mesylate and cytarabine on the proliferation and survival of leukemic cells with clinical response in patients treated with this regimen
OUTLINE This is a dose-escalation study of imatinib mesylate
Patients receive oral imatinib mesylate once daily on days 1-15 and cladribine IV over 2 hours and cytarabine IV over 4 hours on days 3-7 Patients also receive filgrastim G-CSF subcutaneously on days 2-7 Treatment repeats every 15 days for 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed periodically for up to 1 year
PROJECTED ACCRUAL A total of 12-18 patients 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 |
|---|---|---|---|
| NOVARTIS-CSTI571AUS161 | None | None | None |
| URCC-U26403 | None | None | None |
| URCC-RSRB-10427 | None | None | None |