An interventional study of HLA-mismatched micro-transplantation after induction chemotherapy in Acute Myeloid Leukemia, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 7 sites in France. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Treatment
Inclusion is proceeding too slowly
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.
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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HLA-mismatched micro-transplantation
Other: HLA-mismatched micro-transplantation after induction chemotherapy
HLA-mismatched micro-transplantation after induction chemotherapy
Rate of overall survival
Rate of overall survival will be reported.
Time frame: 2 years
Hematopoietic recovery
Number of platelets will be reported.
Time frame: 3 months
Hematopoietic recovery
Number of neutrophils will be reported.
Time frame: 3 months
Hematopoietic recovery
Percentage of leukaemic blasts will be reported.
Time frame: 3 months
Rate of complete remission
Rate of complete remission :
Time frame: 2 years
GVHD (graft versus host disease)
Presence of graft versus host disease will be reported.
Time frame: 2 years
Median overall survival
Median overall survival will be calculated.
Time frame: 2 years
Median progression-free survival
Median progression-free survival will be calculated.
Time frame: 2 years
Microchimerism
Presence of microchimerism will be reported.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Jan 2024, 60 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 13, 2026: primary completion Dec 2025 → Jan 2024 and completion Dec 2027 → Jul 2024.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
Inclusion is proceeding too slowly
Inclusion is proceeding too slowly
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne →