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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


N/A
15 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

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


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.

PROJECTED ACCRUAL: A total of 451 patients will be accrued for this study.

Inclusion 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

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Sherif S. Farag, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

Unspecified

Study ID:

CDR0000352018

NCT ID:

NCT00896701

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Leukemia
  • adult acute myeloid leukemia in remission
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Kinston Medical SpecialistsKinston, North Carolina  28501