Relationship Between Natural Killer Cells' Ability to Kill Leukemia Cells and the Outcome of Patients With Acute Myeloid Leukemia Previously Treated With Interleukin-2

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00896701

Collaborator

National Cancer Institute (NCI) (NIH)

451

Enrollment

Locations

123

Duration (Months)

225.5

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

451 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Jan 1, 2004

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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]
Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
2	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210-1240