Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: HLA-mismatched micro-transplantation after induction chemotherapy

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 Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jérôme Cornillon, MD; Phone Number: +33 04 77 91 67 26; Email: jerome.cornillon@chu-st-etienne.fr
• Study Contact Backup: Name: Elisabeth Daguenet, PhD; Phone Number: +33 04 77 91 70 89; Email: elisabeth.daguenet@chu-st-etienne.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • Chu Estaing
    • Contact: Jacques-Olivier Bay, MD
    • Principal Investigator: Jacques-Olivier Bay, MD
    • Sub-Investigator: Romain Guieze, MD
    • Sub-Investigator: Eric Hermet, MD
    • Sub-Investigator: Richard Lemal, MD
    • Sub-Investigator: Aurélie Ravinet, MD
    • Sub-Investigator: Olivier Tournilhac, MD
    • Sub-Investigator: Amandine Fayard, MD
    • Sub-Investigator: Victoria CACHEUX, MD
  • Grenoble, France
    • Recruiting
    • Centre Hospitalier Universitaire de Grenoble
    • Contact: Claude-Eric Bulabois, MD
    • Principal Investigator: Claude-Eric Bulabois
    • Sub-Investigator: Martin Carré
    • Sub-Investigator: Anne Thiébaut
  • Lille, France
    • Not yet recruiting
    • CHRU de Lille
    • Contact: Micha Srour
    • Principal Investigator: Micha Srour, MD
    • Sub-Investigator: David Beauvais, MD
    • Sub-Investigator: Valérie Coiteux, MD
    • Sub-Investigator: Leonardo Magro, MD
    • Sub-Investigator: Ibrahim Yakoub-Agha, MD
  • Lyon, France
    • Recruiting
    • Centre Hospitalier Lyon Sud
    • Contact: Hélène Labussière-Wallet, MD
    • Sub-Investigator: Marie Balsat, MD
    • Sub-Investigator: Fiorenza Barraco, MD
    • Sub-Investigator: Sophie Ducastelle-Lepretre, MD
    • Sub-Investigator: Gaëlle Fossard, MD
    • Sub-Investigator: Maël Heiblig, MD
    • Sub-Investigator: Marie-Virginie Larcher, MD
    • Sub-Investigator: Sandrine Loron, MD
  • Nancy, France
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Nancy
    • Contact: Arnaud Campidelli, MD
    • Principal Investigator: Arnaud Campidelli
    • Sub-Investigator: Maud D'Aveni
    • Sub-Investigator: Marie Detrait
    • Sub-Investigator: Marie-Thérèse Rubio
  • Paris, France
    • Not yet recruiting
    • Hôpital de la Pitié-Salpétrière
    • Contact: Stéphanie Nguyen, MD
    • Principal Investigator: Stéphanie Nguyen, MD
    • Sub-Investigator: Laetitia Souchet, MD
    • Sub-Investigator: Madalina Uzunov, MD
  • Saint-Étienne, France, 42055
    • Recruiting
    • CHU DE SAINT-ETIENNE
    • Contact: Jérôme Cornillon, MD
    • Principal Investigator: Jérôme CORNILLON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLA-mismatched micro-transplantation	Other: HLA-mismatched micro-transplantation after induction chemotherapy; HLA-mismatched micro-transplantation after induction chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of overall survival	Rate of overall survival will be reported.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematopoietic recovery	Number of platelets will be reported.	3 months
Hematopoietic recovery	Number of neutrophils will be reported.	3 months
Hematopoietic recovery	Percentage of leukaemic blasts will be reported.	3 months
Rate of complete remission	Rate of complete remission :	2 years
GVHD (graft versus host disease)	Presence of graft versus host disease will be reported.	2 years
Median overall survival	Median overall survival will be calculated.	2 years
Median progression-free survival	Median progression-free survival will be calculated.	2 years
Microchimerism	Presence of microchimerism will be reported.	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire
• Investigators: Principal Investigator: Jérôme Cornillon, MD, CHU DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Acute Myeloid Leukemia; Micro-transplantation; Graft-versus-leukemia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 2017-1201; 2017-A03572-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No