Use of the MiCK Assay for Apoptosis in AML

Leukemia, Myelocytic, Acute Clinical Trial

Official title:

Use of the MiCK Assay for Apoptosis to Predict Complete Remission in Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286845
• Other study ID #: Diatech Leuk II Vand
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2006
• Last updated: January 25, 2012
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: DiaTech Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

STUDY DESIGN

1. Recruit patients and assign them unique number at the time of sample collection. All samples and data will be recorded by unique number. The key to the unique numbers assigned to each patient will be kept by the principal investigators at Vanderbilt.

2. After obtaining informed consent, collect specimens from patients whose induction therapy will include cytarabine and idarubicin. Collect and ship to DiaTech by overnight courier fifty (50) bone marrow or peripheral blood [if available, both bone marrow and peripheral blood] specimens from newly diagnosed patients with AML. Newly diagnosed AML patients include those diagnosed de novo or arising from a previously diagnosed myelodysplastic syndrome, but do not include patients with previously treated leukemia that has relapsed. An adequate specimen for analysis will contain sufficient numbers of viable leukemia cells to perform the MiCK assay with 7 doses of cytarabine and 7 doses of idarubicin..

3. Each patient's clinically recognized predictors of leukemia treatment outcome will be recorded. These predictors include age, sex, presence or absence of preceding myelodysplastic syndrome, blood leukocyte count at diagnosis, percentage of leukemic cells in the blood, and leukemic cell karyotype.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

patients with newly diagnosed acute myeloid leukemia (AML

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Standard Chemotherapy
physician determined

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center and DiaTech Oncology	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
DiaTech Oncology	DiaTech Oncology and Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Kravtsov VD, Fabian I. Automated monitoring of apoptosis in suspension cell cultures. Lab Invest. 1996 Feb;74(2):557-70. — View Citation

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. — View Citation

Kravtsov VD. A novel microculture kinetic assay (MiCK assay) for malignant cell growth and chemosensitivity. Eur J Cancer. 1994;30A(10):1564-70. — View Citation

External Links

•   DiaTech Oncology website.