Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-28 @ 2:51 AM
Study NCT ID:
NCT01575535
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2012-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
Study Overview
Official Title:
S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications
Status:
COMPLETED
Status Verified Date:
2015-03
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 from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.
PURPOSE: This research trial studies bone marrow samples from women with acute myeloid leukemia.
Detailed Description:
OBJECTIVES:
* Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
* Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
* Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.
OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.
* Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors.
* Explore whether there is an association between the cellular origin of AML (i.e., origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient characteristics.
* Explore whether overall survival (OS), event-free survival (EFS), disease-free survival (DFS), response rate (RR), or relapse rate is improved for patients with AMLs that originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+ precursors compared to patients with clonally involved cells not detected.
OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. Results are then compared with each patient clinical data.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| S0106B | OTHER | SWOG | View | |
| U10CA032102 | NIH | None | https://reporter.nih.gov/quic… | View |