Imatinib Mesylate, Daunorubicin, and Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00268229|
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : February 15, 2013
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin and cytarabine 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 daunorubicin and cytarabine in treating patients with relapsed acute myeloid leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cytarabine Drug: daunorubicin hydrochloride Drug: imatinib mesylate||Phase 1|
- Determine the maximum tolerated dose (MTD) and recommended phase II dose of imatinib mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with relapsed acute myeloid leukemia.
- Assess the non-dose-limiting toxicities associated with this regimen in these patients.
- Determine any preliminary evidence of clinical activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of imatinib mesylate.
Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive oral imatinib mesylate once daily beginning on day 1 and continuing until disease progression or unacceptable toxicity. Patients with persistent leukemia on day 14 bone marrow biopsy but ≥ 50% reduction in bone marrow blasts receive 5 more days of cytarabine and 2 more days of daunorubicin while continuing imatinib mesylate.
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 1 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Imatinib Mesylate (Gleevec, Formerly Known as STI571) in Combination With Daunorubicin and Cytarabine for C-kit Positive Relapsed AML|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
- Drug: cytarabine
- Drug: daunorubicin hydrochloride
- Drug: imatinib mesylate
dose escalation (300 mg/day to 800 mg/day).
- Maximum tolerated dose of imatinib mesylate at one year [ Time Frame: 1 year ]
- Non-dose limiting toxicities associated with imatinib mesylate at one year [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268229
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Anjali Advani, MD||The Cleveland Clinic|