Clinical trial 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: 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)
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 451
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival
timeFrame: Up to 10 years
measure: Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival
timeFrame: Up to 10 years
measure: Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival
timeFrame: Up to 10 years
measure: Comparison of the susceptibility to autologous NK cell lysis of leukemic blasts obtained at diagnosis with those blasts obtained at relapse
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kinston
country: United States
facility: Kinston Medical Specialists
state: North Carolina
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Sherif S. Farag, MD, PhD
role: STUDY_CHAIR
References: