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

NCT ID: NCT00918658

Last Updated: 2015-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia Multiple Myeloma and Plasma Cell Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with hematologic cancer

Patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma

biologic sample preservation procedure

Intervention Type OTHER

All specimens will be collected using the Pathology Residual Tissue Procurement.

immunologic technique

Intervention Type OTHER

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

laboratory biomarker analysis

Intervention Type OTHER

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.

Patients without cancer

Patients who do not have cancer.

biologic sample preservation procedure

Intervention Type OTHER

All specimens will be collected using the Pathology Residual Tissue Procurement.

immunologic technique

Intervention Type OTHER

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

laboratory biomarker analysis

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

biologic sample preservation procedure

All specimens will be collected using the Pathology Residual Tissue Procurement.

Intervention Type OTHER

immunologic technique

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rose Beck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE2Z08

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-2Z08-CC502

Identifier Type: OTHER

Identifier Source: secondary_id

CASE2Z08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biology Studies of Hematologic Cancers
NCT00923442 ENROLLING_BY_INVITATION