- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
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
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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-
North Carolina
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Kinston, North Carolina, Förenta staterna, 28501
- Kinston Medical Specialists
-
-
Ohio
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Columbus, Ohio, Förenta staterna, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Patient samples from C9621, C9720 and C19808
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival
Tidsram: Up to 10 years
|
Up to 10 years
|
Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival
Tidsram: Up to 10 years
|
Up to 10 years
|
Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival
Tidsram: Up to 10 years
|
Up to 10 years
|
Comparison of the susceptibility to autologous NK cell lysis of leukemic blasts obtained at diagnosis with those blasts obtained at relapse
Tidsram: Up to 10 years
|
Up to 10 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studiestol: Sherif S. Farag, MD, PhD, Indiana University Melvin and Bren Simon Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- akut myeloid leukemi hos vuxna med 11q23 (MLL) abnormiteter
- akut myeloid leukemi hos vuxna med inv(16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(15;17)(q22;q12)
- akut myeloid leukemi hos vuxna med t(16;16)(p13;q22)
- akut myeloid leukemi hos vuxna med t(8;21)(q22;q22)
- återkommande akut myeloid leukemi hos vuxna
- akut myeloid leukemi hos vuxna i remission
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CALGB-20206
- CDR0000352018 (Registeridentifierare: NCI Physician Data Query)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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