Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01360125
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2011-05-21
Brief Title:
S0106A Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
S0106A Proteomic Signatures Associated With Complete Response CR and Complete Continuous Response at One Year CCR1 Following Cytarabine-Based Induction Chemotherapy in Younger Adult Patients 18-60 Years of Age With a Newly Diagnosed Non-M3 AML
Status:
COMPLETED
Status Verified Date:
2016-04
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:
RATIONALE Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment
PURPOSE This research study studies biomarkers in samples from patients with newly diagnosed acute myeloid leukemia treated with cytarabine-based chemotherapy
PURPOSE This research study studies biomarkers in samples from patients with newly diagnosed acute myeloid leukemia treated with cytarabine-based chemotherapy
Detailed Description:
OBJECTIVES
Training and testing of multiparameter flow cytometry-based cell signaling signature FC classifier 1 associated with in vivo primary chemoresistance ie non-complete response NR to standard induction therapy in adult patients 60 years old with a newly diagnosed non-M3 acute myeloid leukemia AML
Training and testing of multiparameter flow cytometry-based cell signaling signature FC classifier 2 associated with complete continuous response at 1 year CCR1 in adult patients 60 years old with a newly diagnosed non-M3 AML who are treated with cytarabine-based induction chemotherapy
Identification of signaling signatures associated with secondary chemoresistance ie disease relapse in adult patients 60 years of age who have longitudinally paired peripheral blood mononuclear cells PBMC or bone marrow mononuclear cells BMMC samples at diagnosis and at the time of first relapse Exploratory
OUTLINE Cryopreserved samples are incubated with cytokines eg interleukins growth factors eg sargramostim GM-CSF and filgrastim G-CSF chemotherapeutic agents eg cytarabine etoposide phosphate and other modulators Cells are fixed permeabilized and stained with antibodies that recognize extracellular markers in conjunction with intracellular activation-state specific epitopes of designated signaling molecules Subsequently cells are analyzed for multiparametric phospho-flow cytometry in a random manner without knowledge of clinical variables and outcomes to training and testing sets Results are then compared with individual patient clinical outcomes
Training and testing of multiparameter flow cytometry-based cell signaling signature FC classifier 1 associated with in vivo primary chemoresistance ie non-complete response NR to standard induction therapy in adult patients 60 years old with a newly diagnosed non-M3 acute myeloid leukemia AML
Training and testing of multiparameter flow cytometry-based cell signaling signature FC classifier 2 associated with complete continuous response at 1 year CCR1 in adult patients 60 years old with a newly diagnosed non-M3 AML who are treated with cytarabine-based induction chemotherapy
Identification of signaling signatures associated with secondary chemoresistance ie disease relapse in adult patients 60 years of age who have longitudinally paired peripheral blood mononuclear cells PBMC or bone marrow mononuclear cells BMMC samples at diagnosis and at the time of first relapse Exploratory
OUTLINE Cryopreserved samples are incubated with cytokines eg interleukins growth factors eg sargramostim GM-CSF and filgrastim G-CSF chemotherapeutic agents eg cytarabine etoposide phosphate and other modulators Cells are fixed permeabilized and stained with antibodies that recognize extracellular markers in conjunction with intracellular activation-state specific epitopes of designated signaling molecules Subsequently cells are analyzed for multiparametric phospho-flow cytometry in a random manner without knowledge of clinical variables and outcomes to training and testing sets Results are then compared with individual patient clinical outcomes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0106A | OTHER | None | None |