Clinical trial · Observational
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
The Development of Predictive Biomarker Models for Patients Receiving Standard Induction Chemotherapy With and Without Gemtuzumab Ozogamicin
NCT01503541CI-TRIAL-00017045completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA analysis | Genetic | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mutation analysis | Genetic | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| RNA analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Biomarker assays in highly purified populations of AML myeloblasts are more predictive of clinical outcomes as compared to the same tests examining unsorted cells
- timeFrame
- immediate
- measure
- Development of risk-assessment biomarker model for clinical outcomes
- timeFrame
- immediate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 88 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.