Acute Myeloid Leukemia or Myelodysplasic SyndromeNCT02525250
Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide
A study testing Realization of 3 Blood samples during study during treatment with lenalidomide in people with Acute Myeloid Leukemia or Myelodysplasic Syndrome, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy. the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia or Myelodysplasic Syndrome
- What is being tested?
- Realization of 3 Blood samples during study during treatment with lenalidomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years and above,
- Patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with Revlimid,
- Signed consent to participate,
- Patient affiliated to a social security system or benefiting from such as a system.
Who cannot join
- Allogeneic patients beyond,
- Patient deprived of liberty or under supervision of a guardian,
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.
the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.
Read more
lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.
It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.
- Being tested
- Realization of 3 Blood samples during study during treatment with lenalidomide
- Keywords
- Acute myeloid leukemia or myelodysplasic syndrome
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realization of 3 Blood samples during study during treatment with lenalidomideProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Acute myeloïd leukemia | Experimental | Realization of 3 blood samples at day 0, day 15 and day 28. Receives: Procedure: Realization of 3 Blood samples during study during treatment with lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of NK functions
Evaluation with blood analysis
Measured: Time from inclusion (Day 0) until Day 28
Secondary outcomes (1)
cytotoxic response therapy
Evaluation of cytotoxic response therapy with lenalidomide
Measured: Time from inclusion until relapse or death (until 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startDec 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia or Myelodysplasic SyndromeStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas PREBET, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525250
- Sponsor's protocol ID
- MDS-AML-NK / IPC-2012-007
- Status last verified
- Jul 2015
- First submitted
- 3 Apr 2013
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT02525250
- Acronym / sponsor ID
- MDS-AML-NK / IPC-2012-007
- Keywords
- Acute myeloid leukemia or myelodysplasic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Aug 2015 (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.
This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.
the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.
lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.
It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myeloïd leukemia | Experimental | Procedure: Realization of 3 Blood samples during study during treatment with lenalidomideRealization of 3 blood samples at day 0, day 15 and day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 years and above,
- Patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with Revlimid,
- Signed consent to participate,
- Patient affiliated to a social security system or benefiting from such as a system.
Key exclusion criteria (3 listed)
- Allogeneic patients beyond,
- Patient deprived of liberty or under supervision of a guardian,
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
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 |
|---|---|---|
| Realization of 3 Blood samples during study during treatment with lenalidomide | Procedure or surgery | Acute myeloïd leukemia |
Primary outcome
Evaluation of NK functions
Time frame: Time from inclusion (Day 0) until Day 28
Evaluation with blood analysis
1 secondary outcome
cytotoxic response therapy
Time frame: Time from inclusion until relapse or death (until 5 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 17 Aug 2015.
- official web site of the sponsorLink provided by the sponsor.
Related trials for Acute Myeloid Leukemia or Myelodysplasic Syndrome
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.
Thomas PREBET, MD principal investigator
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 Realization of 3 Blood samples during study during treatment with lenalidomide in people with Acute Myeloid Leukemia or Myelodysplasic Syndrome, 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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 17 Aug 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 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?
Evaluation of NK functions (time frame: Time from inclusion (Day 0) until Day 28). 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 17 Aug 2015.