NCT Number: NCT00896701
Relationship Between Natural Killer Cells' Ability to Kill Leukemia Cells and the Outcome of Patients With Acute Myeloid Leukemia Previously Treated With Interleukin-2
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
15 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Kinston Medical Specialists, Kinston, North Carolina, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
- Prior treatment with interleukin-2 required
- Previously enrolled on CLB-9621, CLB-9720, or CALGB-19808
- Previously consented to companion Leukemia Tissue Bank Protocol CALGB-9665 and stored the following specimens:
- Bone marrow blast cells procured at diagnosis and at relapse (when available)
- Peripheral blood mononuclear cells obtained in remission
PATIENT CHARACTERISTICS:
Age
- 15 and over
Treatment and study plan
immunologic technique
Otherlaboratory biomarker analysis
OtherPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study 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
Important dates
- Study start
- 2004
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- May 12, 2009
- Registry last updated
- Jul 13, 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.
Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer
NCT00534430
Anemia, Anemia, Refractory
View Trial DetailsAuto 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 DetailsAlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
NCT00547196
Blast Crisis, Bone Marrow Diseases
Phoenix, Arizona, United States
View Trial DetailsEmpirical Versus Preemptive Antifungal Therapy
NCT01288378
Bacterial Infections and Mycoses, Bone Marrow Diseases
Bruges, Belgium
View Trial Details