Acute Myeloid LeukemiaPhase 1MICROSTEMNCT03232268
HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
A Phase 1 study testing HLA-mismatched microtransplantation in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- HLA-mismatched microtransplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2018to 7 Jan 2026
- Phase
- Phase 1
- 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
- Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning)
- HLA-partially matched family donors
- Affiliated to(or beneficiary of) the Social Security
- Informed consent signed
Who cannot join
- AML3
- Previous Hematopoietic Stem Cell TRansplantation
- Uncontrolled infection -PS>3 -Other progressive cancer
- Psychiatric disease
- Vulnerable person or unable to provide informed consent
- Emergency
- Unable to comply with required study follow up
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- HLA-mismatched microtransplantation
- Keywords
- Microtransplantation, Myeloid Hemopathy
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-mismatched microtransplantationBiological
3 administrations of hematopoietic stem cells without immunosupression
| Study group | Role | What they receive |
|---|---|---|
| HLA-mismatched microtransplantation | Experimental | HLA-mismatched microtransplantation without immunosuppressive treatment Receives: Biological: HLA-mismatched microtransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Cumulative incidence of acute GVH (grade 1 to 4)
Measured: 100 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start9 Mar 2018
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232268
- Sponsor's protocol ID
- MICROSTEM- IPC 2016-013
- Acronym
- MICROSTEM
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2017
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
- ClinicalTrials.gov ID
- NCT03232268
- Acronym / sponsor ID
- MICROSTEM / MICROSTEM- IPC 2016-013
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- Microtransplantation, Myeloid Hemopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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 study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLA-mismatched microtransplantation | Experimental | Biological: HLA-mismatched microtransplantationHLA-mismatched microtransplantation without immunosuppressive treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age<65 years with an ineligibility to allograft (contraindication to conditioning)
- HLA-partially matched family donors
- Affiliated to(or beneficiary of) the Social Security
- Informed consent signed
Key exclusion criteria (7 listed)
- AML3
- Previous Hematopoietic Stem Cell TRansplantation
- Uncontrolled infection -PS>3 -Other progressive cancer
- Psychiatric disease
- Vulnerable person or unable to provide informed consent
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 |
|---|---|---|
| HLA-mismatched microtransplantation3 administrations of hematopoietic stem cells without immunosupression | Biological | HLA-mismatched microtransplantation |
Primary outcome
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
Time frame: 100 days after transplantation
Cumulative incidence of acute GVH (grade 1 to 4)
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 14 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLA-mismatched microtransplantation in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, 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 7 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 14 Oct 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment (time frame: 100 days after transplantation). 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 14 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.