Acute Myeloid LeukemiaMTSANCT03439371
Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia
A study testing HLA-mismatched micro-transplantation after induction chemotherapy in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites in France.
Trial summary
This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- HLA-mismatched micro-transplantation after induction chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 7 sitesFrance
- Study dates
- 8 Jan 2019to 4 Jul 2024
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (<5% blasts)
- Contra-indication to conditioning regimen in conventional allogeneic transplantation
Who cannot join
- Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
- Promyelocytic leukemia t(15;17)
- CBF-AML t(8;21) or inv(16)
- Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- Refusing participation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Estaing
Clermont-Ferrand, 63000
Centre Hospitalier Universitaire de Grenoble
Grenoble
CHRU de Lille
Lille
Centre Hospitalier Lyon Sud
Lyon
Centre Hospitalier Universitaire de Nancy
Nancy
Hôpital de la Pitié-Salpêtrière
Paris
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)
This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.
Read the detailed description
Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- HLA-mismatched micro-transplantation after induction chemotherapy
- Keywords
- Acute Myeloid Leukemia, Micro-transplantation, Elderly, Graft-versus-leukemia
- 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.
HLA-mismatched micro-transplantation after induction chemotherapyOther
HLA-mismatched micro-transplantation after induction chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| HLA-mismatched micro-transplantation | Experimental | HLA-mismatched micro-transplantation Receives: Other: HLA-mismatched micro-transplantation after induction chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall survival
Rate of overall survival will be reported.
Measured: 2 years
Secondary outcomes (8)
Hematopoietic recovery
Number of platelets will be reported.
Measured: 3 months
Hematopoietic recovery
Number of neutrophils will be reported.
Measured: 3 months
Hematopoietic recovery
Percentage of leukaemic blasts will be reported.
Measured: 3 months
Rate of complete remission
Rate of complete remission :
Measured: 2 years
GVHD (graft versus host disease)
Presence of graft versus host disease will be reported.
Measured: 2 years
Median overall survival
Median overall survival will be calculated.
Measured: 2 years
Median progression-free survival
Median progression-free survival will be calculated.
Measured: 2 years
Microchimerism
Presence of microchimerism will be reported.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start8 Jan 2019
- Primary completion10 Jan 2024
- Study completion4 Jul 2024
Why it stopped: Inclusion is proceeding too slowly
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Responsible party
- Sponsor
- Investigators
- Jérôme Cornillon, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439371
- Sponsor's protocol ID
- 2017-1201
- Other IDs
- 2017-A03572-51
- Acronym
- MTSA
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)
- ClinicalTrials.gov ID
- NCT03439371
- Acronym / sponsor ID
- MTSA / 2017-1201
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Micro-transplantation, Elderly, Graft-versus-leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion is proceeding too slowly
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Institut de Cancérologie de la Loire
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 20 Feb 2018 (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 and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.
Detailed description
Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.
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 micro-transplantation | Experimental | Other: HLA-mismatched micro-transplantation after induction chemotherapyHLA-mismatched micro-transplantation |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (<5% blasts)
- Contra-indication to conditioning regimen in conventional allogeneic transplantation
Key exclusion criteria (6 listed)
- Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
- Promyelocytic leukemia t(15;17)
- CBF-AML t(8;21) or inv(16)
- Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
- Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the 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 micro-transplantation after induction chemotherapyHLA-mismatched micro-transplantation after induction chemotherapy | Other | HLA-mismatched micro-transplantation |
Primary outcome
Rate of overall survival
Time frame: 2 years
Rate of overall survival will be reported.
8 secondary outcomes
Hematopoietic recovery
Time frame: 3 months
Hematopoietic recovery
Time frame: 3 months
Hematopoietic recovery
Time frame: 3 months
Rate of complete remission
Time frame: 2 years
GVHD (graft versus host disease)
Time frame: 2 years
Median overall survival
Time frame: 2 years
Median progression-free survival
Time frame: 2 years
Microchimerism
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Inclusion is proceeding too slowly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
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RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
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ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
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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.
Jérôme Cornillon, MD principal investigator
CHU de Saint-Etienne
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLA-mismatched micro-transplantation after induction chemotherapy in people with Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire de Saint Etienne at 7 sites 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 6 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: stopped early, as of the sponsor's last update on 13 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 7 sites 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 was stopped early (reason given: Inclusion is proceeding too slowly). Results are not available in the source record.
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?
Rate of overall survival (time frame: 2 years). 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 Oct 2026.