Relationship Between Natural Killer Cells' Ability to Kill Leukemia Cells and the Outcome of Patients With Acute Myeloid Leukemia Previously Treated With Interleukin-2
- Conditions
- Leukemia
- Interventions
- Other: flow cytometryOther: immunologic techniqueOther: laboratory biomarker analysis
- Registration Number
- NCT00896701
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient samples from C9621, C9720 and C19808 flow cytometry 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. Patient samples from C9621, C9720 and C19808 immunologic technique 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. Patient samples from C9621, C9720 and C19808 laboratory biomarker analysis 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.
- Primary Outcome Measures
Name Time Method Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival Up to 10 years Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival Up to 10 years Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival 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 Up to 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States