AMLIMODLAMNCT02888522
Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML
An observational study of AML, run by University Hospital, Caen at 1 site in France.
Trial summary
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML
- What is being tested?
- immunomodulation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute myeloid leukemia
Who may be able to join
- Acute myeloid leukemia
- Allogeneic stem cell transplantation (related or unrelated)
Who cannot join
- Age under 18 years
- Cord blood transplantation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Caen, 14000
Sylvain P Chantepie, MD, +33231272073, chantepie-s@chu-caen.fr
Sylvain P Chantepie, MD
About this study
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.
The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.
- Conditions
- AML
- Being tested
- immunomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunomodulationBiological
Immunomodulation depending on chimerism
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of recipient chimerism
whole blood chimerism
Measured: 3 months
Secondary outcomes (1)
Percentage of relapse at 1 year
Measured: Relapse rate at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888522
- Sponsor's protocol ID
- 15-182
- Acronym
- IMODLAM
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML
- ClinicalTrials.gov ID
- NCT02888522
- Acronym / sponsor ID
- IMODLAM / 15-182
- Conditions
- AML
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Sep 2016 (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.
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.
The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute myeloid leukemia
Key inclusion criteria (2 listed)
- Acute myeloid leukemia
- Allogeneic stem cell transplantation (related or unrelated)
Key exclusion criteria (2 listed)
- Age under 18 years
- Cord blood transplantation
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 |
|---|---|---|
| immunomodulationImmunomodulation depending on chimerism | Biological | – |
Primary outcome
Percentage of recipient chimerism
Time frame: 3 months
whole blood chimerism
1 secondary outcome
Percentage of relapse at 1 year
Time frame: Relapse rate at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
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 AML, run by University Hospital, Caen 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of recipient chimerism (time frame: 3 months). 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 22 Apr 2019; AzTrials last refreshed its copy on 3 Nov 2026.