Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With and Without Hematologic Cancer

Leukemia Clinical Trial

Official title:

Collection of Bone Marrow and Peripheral Blood for Testing of Notch-induced Natural Killer Cell Activity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00918658
• Other study ID #: CASE2Z08
• Secondary ID: P30CA043703CASE2
• Status: Terminated
• Phase: N/A
• First received: June 10, 2009
• Last updated: October 8, 2015
• Start date: April 2008
• Est. completion date: March 2011

Study information

• Verified date: October 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors find better ways to treat the cancer.

PURPOSE: This research study is looking at natural killer cells in bone marrow and blood samples from patients with hematologic cancer and from patients who do not have cancer.

Description:

OBJECTIVES:

• To collect normal and malignant cells in bone marrow and peripheral blood samples from patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma and from patients with no malignancy to use as target cells in cytotoxicity assays.

• To collect information about HLA type and immunophenotype of malignant cells as determined by clinical flow cytometry.

OUTLINE: Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.

Information about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Meets one of the following criteria:

• No evidence of malignancy

• Diagnosis of one of the following:

• Acute myeloid leukemia

• Acute lymphoblastic leukemia

• Chronic myelogenous leukemia

• Multiple myeloma

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Other:
• biologic sample preservation procedure
All specimens will be collected using the Pathology Residual Tissue Procurement.
• immunologic technique
Information about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record.
• laboratory biomarker analysis
Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of normal and malignant cells to use as target cells in cytotoxicity assays		We anticipate collecting approximately 30 samples in total, over a 1-2 year period.	No