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Use of the MiCK Assay for Apoptosis in AML

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286845
First Posted: February 6, 2006
Last Update Posted: January 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
DiaTech Oncology and Vanderbilt University
Information provided by:
Pierian Biosciences
  Purpose

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


Condition Intervention Phase
Leukemia, Myelocytic, Acute Drug: Standard Chemotherapy Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Use of the MiCK Assay for Apoptosis to Predict Complete Remission in Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Pierian Biosciences:

Estimated Enrollment: 50
Study Start Date: January 2006
Study Completion Date: December 2009
Groups/Cohorts Assigned Interventions
II Drug: Standard Chemotherapy
physician determined
1

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

patients with newly diagnosed acute myeloid leukemia (AML

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

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): NCT00286845


Locations
United States, Tennessee
Vanderbilt University Medical Center and DiaTech Oncology
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Pierian Biosciences
DiaTech Oncology and Vanderbilt University
Investigators
Principal Investigator: Cary Presant, MD Pierian Biosciences
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cary Presant, MD, DiaTech Oncology
ClinicalTrials.gov Identifier: NCT00286845     History of Changes
Other Study ID Numbers: Diatech Leuk II Vand
First Submitted: January 16, 2006
First Posted: February 6, 2006
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Pierian Biosciences:
Chemosensitivity
Acute Myeloid Leukemia
Apoptosis
MiCK Assay

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms