NCT Number: NCT01360125
S0106A, Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Observational
About this study
OBJECTIVES:
- Training and testing of multiparameter flow cytometry-based cell signaling signature (FC classifier 1) associated with in vivo primary chemoresistance (i.e., 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 signature(s) associated with secondary chemoresistance (i.e., 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 (e.g., interleukins), growth factors (e.g., sargramostim [GM-CSF] and filgrastim [G-CSF]), chemotherapeutic agents (e.g., 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Newly diagnosed non-M3 acute myeloid leukemia (AML)
- Pretreatment and relapsed and/or refractory cryopreserved bone marrow mononuclear cells (BMMCs) and peripheral blood mononuclear cells (PBMCs) available
- Have 2+ vials of pretreatment marrow cells and/or 2+ vials of pretreatment PBMCs in the Southwestern Oncology Group (SWOG) AML/Myelodysplastic Syndrome (MDS) Repository
- Usable samples must contain approximately 1.6 ×10^6 cluster of differentiation antigen 45+ (CD45+) cells post thaw.
- Eligible and evaluable patients who participated on SWOG-S0106 study
PATIENT CHARACTERISTICS:
- Did not refuse consent for this use of specimens
PRIOR CONCURRENT THERAPY:
- Not specified
Treatment and study plan
flow cytometry
Otherlaboratory biomarker analysis
OtherPrimary outcomes
-
Response to induction chemotherapy (complete response vs non-complete response) (classifier 1)
Time frame: immediate
-
CCR1 at 1 year (classifier 2)
Time frame: immediate
Sponsors and collaborators
Lead sponsor
SWOG Cancer Research Network
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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
Important dates
- Study start
- 2011
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- May 25, 2011
- Registry last updated
- Apr 15, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Auto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R
NCT00534469
Bone Marrow Diseases, Congenital Abnormalities
View Trial DetailsEverolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01154439
Bone Marrow Diseases, Congenital Abnormalities
Bari, Italy
View Trial DetailsCombination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT00372593
Bone Marrow Diseases, Congenital Abnormalities
Birmingham, Alabama, United States
View Trial DetailsImatinib Mesylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Who Have Received Chemotherapy
NCT00509093
Bone Marrow Diseases, Congenital Abnormalities
Buffalo, New York, United States
View Trial Details