Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

NCT ID: NCT03439371

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2027-12-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLA-mismatched micro-transplantation

HLA-mismatched micro-transplantation

Group Type: EXPERIMENTAL

HLA-mismatched micro-transplantation after induction chemotherapy

Intervention Type: OTHER

HLA-mismatched micro-transplantation after induction chemotherapy

Interventions

HLA-mismatched micro-transplantation after induction chemotherapy

HLA-mismatched micro-transplantation after induction chemotherapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérôme Cornillon, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU Estaing

Clermont-Ferrand, , France

Site Status: RECRUITING

Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Site Status: RECRUITING

CHRU de Lille

Lille, , France

Site Status: NOT_YET_RECRUITING

Centre Hospitalier Lyon Sud

Lyon, , France

Site Status: RECRUITING

Centre Hospitalier Universitaire de Nancy

Nancy, , France

Site Status: NOT_YET_RECRUITING

Hôpital de la Pitié-Salpêtrière

Paris, , France

Site Status: NOT_YET_RECRUITING

CHU de Saint-Etienne

Saint-Etienne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jérôme Cornillon, MD

Role: CONTACT

jerome.cornillon@chu-st-etienne.fr

04 77 91 67 26 ext. +33

Elisabeth Daguenet, PhD

Role: CONTACT

elisabeth.daguenet@chu-st-etienne.fr

04 77 91 70 89 ext. +33

Facility Contacts

Jacques-Olivier Bay, MD

Role: primary

Claude-Eric Bulabois, MD

Role: primary

Micha Srour

Role: primary

Hélène Labussière-Wallet, MD

Role: primary

Arnaud Campidelli, MD

Role: primary

Stéphanie Nguyen, MD

Role: primary

Jérôme Cornillon, MD

Role: primary

Other Identifiers

2017-A03572-51

Identifier Type: OTHER

Identifier Source: secondary_id

2017-1201

Identifier Type: -

Identifier Source: org_study_id