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

Brief Summary

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”

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.

  • Study Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis

Arms, Groups and Cohorts in this Clinical Trial

  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival
    • Time Frame: Up to 10 years
      Safety Issue?: No
  • Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival
    • Time Frame: Up to 10 years
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Alliance for Clinical Trials in Oncology
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sherif S. Farag, MD, PhD, Study Chair, Indiana University Melvin and Bren Simon Cancer Center

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00896701