LeukemiaNCT00918658
Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With and Without Hematologic Cancer
An observational study of Leukemia and Multiple Myeloma and Plasma Cell Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia, Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- biologic sample preservation procedure, immunologic technique and laboratory biomarker analysis
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Collection of Bone Marrow and Peripheral Blood for Testing of Notch-induced Natural Killer Cell Activity
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.
Read the detailed 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.
- Being tested
- biologic sample preservation procedure, immunologic technique, laboratory biomarker analysis
- Keywords
- childhood chronic myelogenous leukemia, chronic myelogenous leukemia, adult acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia, adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies, multiple myeloma
- Medical subject headings
- Leukemia, Multiple Myeloma, Neoplasms, Plasma Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
All specimens will be collected using the Pathology Residual Tissue Procurement.
immunologic techniqueOther
Information about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record.
laboratory biomarker analysisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hematologic cancer | Patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma Receives: Other: biologic sample preservation procedure; Other: immunologic technique; Other: laboratory biomarker analysis | |
| Patients without cancer | Patients who do not have cancer. Receives: Other: biologic sample preservation procedure; Other: immunologic technique; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of normal and malignant cells to use as target cells in cytotoxicity assays
Measured: We anticipate collecting approximately 30 samples in total, over a 1-2 year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: PI closed lab
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rose Beck, MD, PhD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918658
- Sponsor's protocol ID
- CASE2Z08
- Other IDs
- P30CA043703, CASE2Z08, CASE-2Z08-CC502
- Status last verified
- Oct 2015
- First submitted
- 10 Jun 2009
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Bone Marrow and Peripheral Blood for Testing of Notch-induced Natural Killer Cell Activity
- ClinicalTrials.gov ID
- NCT00918658
- Acronym / sponsor ID
- CASE2Z08
- Keywords
- childhood chronic myelogenous leukemia, chronic myelogenous leukemia, adult acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia, adult acute myeloid leukemia, childhood acute myeloid leukemia/other myeloid malignancies, multiple myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI closed lab
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hematologic cancer | – | Other: biologic sample preservation procedure, Other: immunologic technique, Other: laboratory biomarker analysisPatients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma |
| Patients without cancer | – | Other: biologic sample preservation procedure, Other: immunologic technique, Other: laboratory biomarker analysisPatients who do not have cancer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic sample preservation procedureAll specimens will be collected using the Pathology Residual Tissue Procurement. | Other | Patients with hematologic cancer, Patients without cancer |
| immunologic techniqueInformation about HLA type and immunophenotype of the malignant cells is collected from the patient's medical record. | Other | Patients with hematologic cancer, Patients without cancer |
| laboratory biomarker analysisBone 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. | Other | Patients with hematologic cancer, Patients without cancer |
Primary outcome
Collection of normal and malignant cells to use as target cells in cytotoxicity assays
Time frame: We anticipate collecting approximately 30 samples in total, over a 1-2 year period.
Results and safety
The study was stopped early (reason given: PI closed lab). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Beck, MD, PhD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Multiple Myeloma and Plasma Cell Neoplasm, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI closed lab). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of normal and malignant cells to use as target cells in cytotoxicity assays (time frame: We anticipate collecting approximately 30 samples in total, over a 1-2 year period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2015.