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S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01575535
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : March 6, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date April 10, 2012
First Posted Date April 11, 2012
Last Update Posted Date March 6, 2015
Study Start Date April 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2012)
  • Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test [ Time Frame: May 2012 ]
  • Relationship between emergence of individual mutations [t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, and KIT], clonality, and stage of cell differentiation using Fisher's exact test [ Time Frame: May 2012 ]
  • Associations between survival outcomes (OS, EFS, DFS, RR, and relapse rate) and CD33+ restriction using regression analysis [ Time Frame: May 2012 ]
Original Primary Outcome Measures
 (submitted: April 10, 2012)
  • Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test
  • Relationship between emergence of individual mutations [t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, and KIT], clonality, and stage of cell differentiation using Fisher's exact test
  • Associations between survival outcomes (OS, EFS, DFS, RR, and relapse rate) and CD33+ restriction using regression analysis
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title S0106B Studying Bone Marrow Samples From Women With Acute Myeloid Leukemia
Official Title S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications
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.

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.

Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Repository specimens
Condition Leukemia
Intervention
  • Genetic: gene expression analysis
  • Other: flow cytometry
  • Other: fluorescence activated cell sorting
  • Other: laboratory biomarker analysis
  • Other: medical chart review
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 10, 2012)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnostic bone marrow specimens from female patients with untreated AML undergoing intensive ("3+7"-like) induction chemotherapy
  • Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age > 60 years)

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01575535
Other Study ID Numbers S0106B
S0106B ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor Southwest Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Roland Walter, MD, PhD Fred Hutchinson Cancer Research Center
PRS Account Southwest Oncology Group
Verification Date March 2015