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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Leukemia

Treatments: Other: immunologic technique; Other: laboratory biomarker analysis; Other: flow cytometry

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00896701

CALGB-20206

CDR0000352018 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 451 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

451 participants in 1 patient group

Patient samples from C9621, C9720 and C19808

Description:

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.

Treatment:

Other: flow cytometry

Other: laboratory biomarker analysis

Other: immunologic technique