LeukemiaNCT00896701
Relationship Between Natural Killer Cells' Ability to Kill Leukemia Cells and the Outcome of Patients With Acute Myeloid Leukemia Previously Treated With Interleukin-2
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- flow cytometry, immunologic technique and laboratory biomarker analysis
- How many people
- 451 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Apr 2014
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
Kinston Medical Specialists
Kinston, North Carolina, 28501
About this study
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
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.
Read the detailed description
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.
- Conditions
- Leukemia
- Being tested
- flow cytometry, immunologic technique, laboratory biomarker analysis
- Keywords
- adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow cytometryOther
immunologic techniqueOther
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: flow cytometry; Other: immunologic technique; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival
Measured: Up to 10 years
Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival
Measured: Up to 10 years
Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival
Measured: 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
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2004
- Primary completionApr 2014
- Study completionApr 2014
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 Alliance for Clinical Trials in OncologyThe 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 only
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sherif S. Farag, MD, PhD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896701
- Sponsor's protocol ID
- CALGB-20206
- Other IDs
- CDR0000352018
- Status last verified
- Jul 2016
- First submitted
- 9 May 2009
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00896701
- Acronym / sponsor ID
- CALGB-20206
- Conditions
- Leukemia
- Keywords
- adult acute myeloid leukemia in remission, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 May 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: 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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient samples from C9621, C9720 and C19808 | – | Other: flow cytometry, Other: immunologic technique, Other: laboratory biomarker analysisThis 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
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 |
|---|---|---|
| flow cytometry | Other | Patient samples from C9621, C9720 and C19808 |
| immunologic technique | Other | Patient samples from C9621, C9720 and C19808 |
| laboratory biomarker analysis | Other | Patient samples from C9621, C9720 and C19808 |
Primary outcome
Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival
Time frame: Up to 10 years
Correlation of expression of inhibitory and activating ligands on AML blast cells with relapse-free survival
Time frame: Up to 10 years
Correlation of expression of activating and inhibitory natural killer (NK) receptors on interleukin-2-expanded cells with relapse-free survival
Time frame: 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
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Sherif S. Farag, MD, PhD study chair
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Alliance for Clinical Trials in Oncology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of in vitro lysis of autologous pre-treatment acute myeloid leukemia (AML) blasts with relapse-free survival (time frame: Up to 10 years). The study lists 4 primary outcomes in all. 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 13 Jul 2016.