Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and chemotherapy may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in treating patients who have newly diagnosed chronic myeloid leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia|
- Incidence of dose-limiting toxicity and treatment-related toxicity per dose level
- Rate and duration of molecular response
- Rate and duration of complete hematological response
- Rate and duration of complete cytogenetic response
- Time to treatment failure
- Overall survival
|Study Start Date:||April 2001|
- Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients with newly diagnosed chronic phase chronic myeloid leukemia.
- Determine the feasibility of this regimen as defined by dose-limiting toxicity of this regimen and treatment-related mortality in no more than 5% of these patients.
- Determine the rate and duration of molecular response, complete hematological response, and complete cytogenetic response in patients treated with this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine.
Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028847
|Brugge, Belgium, 8000|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 1200|
|Leuven, Belgium, B-3000|
|Clinique Universitaire De Mont-Godinne|
|Mont-Godinne Yvoir, Belgium, 5530|
|HagaZiekenhuis - Locatie Leyenburg|
|'s-Gravenhage, Netherlands, 2545 CH|
|Meander Medisch Centrum|
|Amersfoort, Netherlands, 3816 CP|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 10P 1HV|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Medisch Spectrum Twente|
|Enschede, Netherlands, 7500 KA|
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 EZ|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, 6500 HB|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Isala Klinieken - locatie Sophia|
|Zwolle, Netherlands, 8000 GK|
|Study Chair:||J.J. Cornelissen, MD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|