LeukemiaNCT00540956
Natural Killer Cells in Older Patients With Acute Myeloid Leukemia
A study testing cytarabine and laboratory biomarker analysis in people with Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy. PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- cytarabine and laboratory biomarker analysis
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to May 2011
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
- No promyelocytic leukemia
- No prior therapy
PATIENT CHARACTERISTICS:
- Hemoglobin > 10 g/dL
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
France1 site
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
About this study
Official title: Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.
RATIONALE: Studying natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.
PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia.
Read the detailed description
OBJECTIVES:
Primary
- Determine the evolution of functional receptors of natural killer (NK) cells after completion of chemotherapy in elderly patients with acute myeloid leukemia in first remission.
Secondary
- Measure the kinetics of cytotoxic functional recovery of NK cells.
- Determine activation markers of NK cells.
OUTLINE: This is a multicenter study.
Patients receive 1 course of consolidation therapy comprising an anthracycline and cytarabine to induce first remission.
Blood is collected on day 0 of the consolidation course and then every 2 weeks for 8 weeks.
- Conditions
- Leukemia
- Being tested
- cytarabine, laboratory biomarker analysis
- Keywords
- untreated adult acute myeloid leukemia, adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), 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, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Acute, Leukemia, Erythroblastic, Acute, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytarabineDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of functional natural killer (NK) cells after chemotherapy
Secondary outcomes (2)
Kinetics of NK cells
Activation markers of NK cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startNov 2006
- Primary completionMay 2011
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 Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Investigators
- Norbert Vey, MD, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540956
- Sponsor's protocol ID
- CDR0000564106
- Other IDs
- IPC-LAM-NK, INCA-RECF0429, IPC-2006/002
- Status last verified
- Jul 2009
- First submitted
- 5 Oct 2007
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study Evaluating the Presence and Function of Natural Killer Cells in Elderly Patients With Acute Myeloid Leukemia in First Remission.
- ClinicalTrials.gov ID
- NCT00540956
- Acronym / sponsor ID
- CDR0000564106
- Conditions
- Leukemia
- Keywords
- untreated adult acute myeloid leukemia, adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- May 2011 (actual)
- First posted
- 8 Oct 2007 (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 natural killer cells in samples of blood from patients with cancer may help doctors find out how these cells are effected by chemotherapy.
PURPOSE: This clinical trial is studying natural killer cells in older patients with acute myeloid leukemia.
Detailed description
OBJECTIVES:
Primary
- Determine the evolution of functional receptors of natural killer (NK) cells after completion of chemotherapy in elderly patients with acute myeloid leukemia in first remission.
Secondary
- Measure the kinetics of cytotoxic functional recovery of NK cells.
- Determine activation markers of NK cells.
OUTLINE: This is a multicenter study.
Patients receive 1 course of consolidation therapy comprising an anthracycline and cytarabine to induce first remission.
Blood is collected on day 0 of the consolidation course and then every 2 weeks for 8 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| cytarabine | Drug | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Evolution of functional natural killer (NK) cells after chemotherapy
2 secondary outcomes
Kinetics of NK cells
Activation markers of NK cells
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 16 May 2011.
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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.
Norbert Vey, MD
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cytarabine and laboratory biomarker analysis in people with Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
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 16 May 2011. 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 France. 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?
Evolution of functional natural killer (NK) cells after chemotherapy. 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 16 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.