Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286845
Status:
COMPLETED
Last Update Posted:
2012-01-26
First Post:
2006-01-16
Brief Title:
Use of the MiCK Assay for Apoptosis in AML
Sponsor:
Pierian Biosciences
Organization:
Pierian Biosciences
Study Overview
Official Title:
Use of the MiCK Assay for Apoptosis to Predict Complete Remission in Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None