Relationship Between Natural Killer Cells' Ability to Kill Leukemia Cells and the Outcome of Patients With Acute Myeloid Leukemia Previously Treated With Interleukin-2
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|ClinicalTrials.gov Identifier: NCT00896701|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 13, 2016
RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors predict response in patients previously treated with interleukin-2.
PURPOSE: This laboratory study is looking at the relationship between natural killer cells' ability to kill leukemia cells and the outcome of patients with acute myeloid leukemia previously treated with interleukin-2.
|Condition or disease||Intervention/treatment|
|Leukemia||Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis|
- Correlate the in vitro lysis of autologous pre-treatment leukemic blast cells by interleukin-2 (IL-2)-expanded natural killer (NK) cells with relapse-free survival of patients with acute myeloid leukemia (AML) who were treated with interleukin-2 (IL-2).
- Correlate the expression of inhibitory (MHC class I) and activating ligands on AML blast cells with relapse-free survival of these patients.
- Correlate the expression of activating and inhibitory NK receptors on IL-2-expanded cells with relapse-free survival of these patients.
- Compare the susceptibility to autologous NK cell lysis of leukemic blasts obtained at diagnosis with those blasts obtained at relapse of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to age (< 60 vs ≥ 60 years) and cytogenetic risk category (favorable vs average vs poor).
Previously banked tissue samples of leukemic blast cells from bone marrow and natural killer (NK) cells from peripheral blood mononuclear cells are thawed and analyzed. Surface expression on leukemic blasts of co-stimulatory molecules, known activating NKG2D ligands, and MHC class I inhibitory ligands to NK cell receptors are quantified by monoclonal antibody analysis and flow cytometry. Mean cell fluorescence intensity (MCFI) of each ligand is correlated with relapse-free survival of the patients.
|Study Type :||Observational|
|Actual Enrollment :||451 participants|
|Official Title:||A Study of the Relationship Between Natural Killer Cell Recognition and Lysis of Autologous Leukemic Blasts and Clinical Outcome of Acute Myeloid Leukemia Patients Treated With Interleukin-2: A CALGB Leukemia Tissue Bank Project|
|Study Start Date :||January 2004|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
Patient samples from C9621, C9720 and C19808
This is a CALGB Leukemia Tissue Bank project that makes use of tissue from patients who have previously provided their consent. Diagnostic and follow-up samples from acute myeloid leukemia (AML) patients treated on CALGB protocols 9621, 9720 and 19808, and who have been registered on the mandatory companion Leukemia Tissue Bank Protocol CALGB 9665 will be used.
|Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis|
- Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival [ Time Frame: Up to 10 years ]
- Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival [ Time Frame: Up to 10 years ]
- Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival [ Time Frame: Up to 10 years ]
- Comparison of the susceptibility to autologous NK cell lysis of leukemic blasts obtained at diagnosis with those blasts obtained at relapse [ Time Frame: Up to 10 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896701
|United States, North Carolina|
|Kinston Medical Specialists|
|Kinston, North Carolina, United States, 28501|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Sherif S. Farag, MD, PhD||Indiana University Melvin and Bren Simon Cancer Center|