CompletedNCT01503541Updated Mar 6, 2015

S9031-9333-0106-0112-A Study of Biomarkers in Samples From Patients With Acute Myeloid Leukemia Treated With Standard Chemotherapy With or Without Gemtuzumab Ozogamicin

An observational study in Leukemia, sponsored by SWOG Cancer Research Network. Completed. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by SWOG Cancer Research Network · Observational

Study type: Observational
Time perspective: Retrospective
Enrollment: 365
Ages: 18 Years to 88 Years
Sex: All

Study summary

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in samples from patients with acute myeloid leukemia treated with standard chemotherapy with or without gemtuzumab ozogamicin.

Read the detailed description

OBJECTIVES:

To determine whether measuring biomarkers in less-differentiated acute myeloid leukemia (AML) blasts significantly improves their predictive accuracy to predict clinical outcomes for patients receiving induction/consolidation chemotherapy with and without gemtuzumab ozogamicin.
To develop and validate novel predictive biomarker models for predicting clinical outcomes for AML patients receiving induction/consolidation chemotherapy with and without gemtuzumab ozogamicin.

OUTLINE: DNA and RNA extracted from archived bone marrow and peripheral blood samples are analyzed for genomic mutations (CEBPA, FLT3, IDH1/2, KIT, NPM1, RUNX1, TP53, and WT1) and transcriptional biomarkers (BAALC, CCNA1, CD34, CEBPA, ERG, EVI1, FLT3, IL3RA, MCL1 [two splice variants], MN1, RUNX1, and WT1) by PCR and real-time PCR. Data are then analyzed by the Gene Scan software.

Conditions studied

Leukemia

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Leukemia 5,442

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 365 is above the median of 120 across 744 observational studies indexed under Leukemia.

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Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 88 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Specimens from patients consenting to future research on S9031, S9333, S0106 and S0112

Eligibility criteria

DISEASE CHARACTERISTICS:

Pretreatment bone marrow (BM) and peripheral blood (PB) samples obtained from Southwest Oncology Group ( SWOG) Leukemia Repository for adult patients enrolled on SWOG-9031, SWOG-9333, SWOG-S0106, and SWOG-S0112
Samples restricted to those patients from these studies with at least 3 or more vials of remaining material in the SWOG Leukemia Repository and vials containing at least 1.5 x 10\^7 cells/vial
Samples from patients who received standard induction with cytarabine (ARA)/daunorubicin hydrochloride (DNR) with the addition of gemtuzumab ozogamicin (Mylotarg®) on one arm of S0106

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Study design

Time perspective: Retrospective
Enrollment: 365 participants (actual)
Patient registry: No

Interventions

GeneticDNA analysis
GeneticRNA analysis
Geneticgene expression analysis
Geneticmutation analysis
Geneticpolymerase chain reaction
Otherlaboratory biomarker analysis

What researchers measure

Primary outcomes

Biomarker assays in highly purified populations of AML myeloblasts are more predictive of clinical outcomes as compared to the same tests examining unsorted cells
Time frame: immediate
Development of risk-assessment biomarker model for clinical outcomes
Time frame: immediate

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01503541
Lead sponsor: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jan 4, 2012
Start date: Dec 2011
Primary completion: Jun 2012
Completion: Jun 2012
Last update: Mar 6, 2015

Study contacts

Derek L. Stirewalt, MD

principal investigator · Fred Hutchinson Cancer Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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