NCT00286845|Completed
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Sponsor study identifier
observational
50
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2009
Actual (reported)A previous preliminary study performed at Vanderbilt University with funding from the Leukemia Society of America demonstrated that the response of leukemia cells in vitro to the chemotherapeutic agent idarubicin in the microculture kinetic assay for apoptosis (MiCK assay) predicted survival in patients with newly diagnosed acute myeloid leukemia (AML). In this previous study, achievement of complete response (CR) to induction therapy with idarubicin and cytarabine was used as the clinical indicator for determining whether leukemia specimens taken prior to treatment were sensitive or not sensitive in the MiCK assay. This group of patients has been followed for 7 years and their long term survival rates show that their responses in the MiCK assay to idarubicin but not cytarabine predict survival. In the present proposal a separate group of patients with newly diagnosed AML will be recruited to provide leukemia cell samples that will be used to establish criteria for sensitivity and non-sensitivity to idarubicin and cytarabine in the MiCK assay. The achievement of CR will be used to determine in vitro sensitivity as it was done in the previous study. With the in vitro sensitivities as determined in this proposed study, the long term survivals of patients in the previous study will be analyzed prospectively. The proposed study is expected to have an approximate duration of one year. Patient population will include newly diagnosed AML patients with both de novo AML and AML arising from a previously diagnosed myelodysplastic syndrome. The study will not include patients with previously treated leukemia that has relapsed
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2006
Actual (reported)February 6, 2006
Actual (reported)December 2009
Actual (reported)physician determined
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Patient population will include newly diagnosed AML patients with both de novo AML and AML arising from a previously diagnosed myelodysplastic syndrome. The study will not include patients with previously treated leukemia that has relapsed
Contact the study team to confirm eligibility.
Vanderbilt University Medical Center and DiaTech Oncology
Nashville, Tennessee, 37212, United States
Kravtsov VD. A novel microculture kinetic assay (MiCK assay) for malignant cell growth and chemosensitivity. Eur J Cancer. 1994;30A(10):1564-70. doi: 10.1016/0959-8049(94)00291-c.
Kravtsov VD, Fabian I. Automated monitoring of apoptosis in suspension cell cultures. Lab Invest. 1996 Feb;74(2):557-70.
Kravtsov VD, Greer JP, Whitlock JA, Koury MJ. Use of the microculture kinetic assay of apoptosis to determine chemosensitivities of leukemias. Blood. 1998 Aug 1;92(3):968-80.
Cary Presant, MD
Pierian Biosciences
First Submitted
January 16, 2006
First Posted
February 6, 2006
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2009
Actual (reported)Kravtsov VD, Daniel TO, Koury MJ. Comparative analysis of different methodological approaches to the in vitro study of drug-induced apoptosis. Am J Pathol. 1999 Oct;155(4):1327-39. doi: 10.1016/S0002-9440(10)65235-2.
Strickland SA, Raptis A, Hallquist A, Rutledge J, Chernick M, Perree M, Talbott MS, Presant CA. Correlation of the microculture-kinetic drug-induced apoptosis assay with patient outcomes in initial treatment of adult acute myelocytic leukemia. Leuk Lymphoma. 2013 Mar;54(3):528-34. doi: 10.3109/10428194.2012.722217. Epub 2012 Sep 17.
Last Updated
January 26, 2012
Record last verified: 2012-01
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