Micro-transplantation for elderly patients with acute myeloid leukemia

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 is testing a new type of transplant for older patients with acute myeloid leukemia who can't have regular transplants to see if it can help them fight the disease better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 60 Years to 75 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Clermont-Ferrand and 6 other locations)
• Trial ID: NCT03439371 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerance of micro-transplantation in elderly patients with acute myeloid leukemia (AML) who cannot undergo conventional allogeneic transplantation. It focuses on patients aged 60 to 75 years with intermediate or adverse-risk cytogenetic profiles. The approach involves administering HLA-mismatched donor cells after induction chemotherapy to achieve a graft-versus-leukemia effect without significant donor engraftment or graft-versus-host disease. The study aims to provide an alternative treatment strategy for older patients facing poor outcomes with standard therapies.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 60 to 75 years with de novo or secondary AML and an intermediate or adverse-risk cytogenetic profile.

Not a fit: Patients with standard-risk cytogenetic profiles or specific types of leukemia such as promyelocytic leukemia or CBF-AML may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for elderly patients with acute myeloid leukemia.

How similar studies have performed: While micro-transplantation is a relatively novel approach, preliminary studies suggest it may offer a promising alternative to traditional transplantation methods.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Clermont-Ferrand and 6 other locations

• CHU Estaing — Clermont-Ferrand, France (Recruiting)
• Centre Hospitalier Universitaire de Grenoble — Grenoble, France (Recruiting)
• CHRU de Lille — Lille, France (Not_yet_recruiting)
• Centre Hospitalier Lyon Sud — Lyon, France (Recruiting)
• Centre Hospitalier Universitaire de Nancy — Nancy, France (Not_yet_recruiting)
• Hôpital de la Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
• CHU de Saint-Etienne — Saint-Etienne, France (Recruiting)

Study contacts

• Principal investigator: Jérôme Cornillon, MD — CHU de Saint-Etienne
• Study coordinator: Jérôme Cornillon, MD

Conditions Acute Myeloid Leukemia; Micro-transplantation; Elderly; Graft-versus-leukemia