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Completed

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinston Medical Specialists, Kinston, North Carolina, United States

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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

flow cytometry

Other

immunologic technique

Other

laboratory biomarker analysis

Other

Primary outcomes

  1. Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival

    Time frame: Up to 10 years

  2. Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival

    Time frame: Up to 10 years

  3. 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

  4. 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.

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