Leukemia Clinical Trial
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
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 451 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Kinston Medical Specialists | Kinston | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival | Up to 10 years | No | |
Primary | Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival | Up to 10 years | No | |
Primary | Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival | Up to 10 years | No | |
Primary | Comparison of the susceptibility to autologous NK cell lysis of leukemic blasts obtained at diagnosis with those blasts obtained at relapse | Up to 10 years | No |
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