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

Primary Purpose

Acute Myeloid Leukemia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

HLA-mismatched micro-transplantation after induction chemotherapy

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, Micro-transplantation, Elderly, Graft-versus-leukemia

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU EstaingRecruiting
Centre Hospitalier Universitaire de GrenobleRecruiting
CHRU de Lille
Centre Hospitalier Lyon SudRecruiting
Centre Hospitalier Universitaire de Nancy
Hôpital de la Pitié-Salpêtrière
CHU de Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLA-mismatched micro-transplantation

Arm Description

HLA-mismatched micro-transplantation

Outcomes

Primary Outcome Measures

Rate of overall survival

Rate of overall survival will be reported.

Secondary Outcome Measures

Hematopoietic recovery

Number of platelets will be reported.

Hematopoietic recovery

Number of neutrophils will be reported.

Hematopoietic recovery

Percentage of leukaemic blasts will be reported.

Rate of complete remission

Rate of complete remission :

GVHD (graft versus host disease)

Presence of graft versus host disease will be reported.

Median overall survival

Median overall survival will be calculated.

Median progression-free survival

Median progression-free survival will be calculated.

Microchimerism

Presence of microchimerism will be reported.

Full Information

NCT ID

NCT03439371

First Posted

February 5, 2018

Last Updated

May 4, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

1. Study Identification

Unique Protocol Identification Number

NCT03439371

Brief Title

Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

Acronym

MTSA

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 8, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, Micro-transplantation, Elderly, Graft-versus-leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HLA-mismatched micro-transplantation

Arm Type

Experimental

Arm Description

HLA-mismatched micro-transplantation

Intervention Type

Other

Intervention Name(s)

HLA-mismatched micro-transplantation after induction chemotherapy

Intervention Description

HLA-mismatched micro-transplantation after induction chemotherapy

Primary Outcome Measure Information:

Title

Rate of overall survival

Description

Rate of overall survival will be reported.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Hematopoietic recovery

Description

Number of platelets will be reported.

Time Frame

3 months

Title

Hematopoietic recovery

Description

Number of neutrophils will be reported.

Time Frame

3 months

Title

Hematopoietic recovery

Description

Percentage of leukaemic blasts will be reported.

Time Frame

3 months

Title

Rate of complete remission

Description

Rate of complete remission :

Time Frame

2 years

Title

GVHD (graft versus host disease)

Description

Presence of graft versus host disease will be reported.

Time Frame

2 years

Title

Median overall survival

Description

Median overall survival will be calculated.

Time Frame

2 years

Title

Median progression-free survival

Description

Median progression-free survival will be calculated.

Time Frame

2 years

Title

Microchimerism

Description

Presence of microchimerism will be reported.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jérôme Cornillon, MD

Phone

04 77 91 67 26

Ext

+33

jerome.cornillon@chu-st-etienne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Elisabeth Daguenet, PhD

Phone

04 77 91 70 89

Ext

+33

elisabeth.daguenet@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jérôme Cornillon, MD

Organizational Affiliation

CHU de Saint-Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Estaing

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacques-Olivier Bay, MD

First Name & Middle Initial & Last Name & Degree

Jacques-Olivier Bay, MD

First Name & Middle Initial & Last Name & Degree

Romain Guieze, MD

First Name & Middle Initial & Last Name & Degree

Eric Hermet, MD

First Name & Middle Initial & Last Name & Degree

Richard Lemal, MD

First Name & Middle Initial & Last Name & Degree

Aurélie Ravinet, MD

First Name & Middle Initial & Last Name & Degree

Olivier Tournilhac, MD

First Name & Middle Initial & Last Name & Degree

Amandine Fayard, MD

First Name & Middle Initial & Last Name & Degree

Victoria Cacheux, MD

Facility Name

Centre Hospitalier Universitaire de Grenoble

City

Grenoble

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claude-Eric Bulabois, MD

First Name & Middle Initial & Last Name & Degree

Claude-Eric Bulabois

First Name & Middle Initial & Last Name & Degree

Martin Carré

First Name & Middle Initial & Last Name & Degree

Anne Thiébaut

Facility Name

CHRU de Lille

City

Lille

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Micha Srour

First Name & Middle Initial & Last Name & Degree

Micha Srour, MD

First Name & Middle Initial & Last Name & Degree

David Beauvais, MD

First Name & Middle Initial & Last Name & Degree

Valérie Coiteux, MD

First Name & Middle Initial & Last Name & Degree

Leonardo Magro, MD

First Name & Middle Initial & Last Name & Degree

Ibrahim Yakoub-Agha, MD

Facility Name

Centre Hospitalier Lyon Sud

City

Lyon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hélène Labussière-Wallet, MD

First Name & Middle Initial & Last Name & Degree

Hélène Labussière-Wallet, MD

First Name & Middle Initial & Last Name & Degree

Marie Balsat, MD

First Name & Middle Initial & Last Name & Degree

Fiorenza Barraco, MD

First Name & Middle Initial & Last Name & Degree

Sophie Ducastelle-Lepretre, MD

First Name & Middle Initial & Last Name & Degree

Gaëlle Fossard, MD

First Name & Middle Initial & Last Name & Degree

Maël Heiblig, MD

First Name & Middle Initial & Last Name & Degree

Marie-Virginie Larcher, MD

First Name & Middle Initial & Last Name & Degree

Sandrine Loron, MD

Facility Name

Centre Hospitalier Universitaire de Nancy

City

Nancy

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud Campidelli, MD

First Name & Middle Initial & Last Name & Degree

Arnaud Campidelli

First Name & Middle Initial & Last Name & Degree

Maud D'Aveni

First Name & Middle Initial & Last Name & Degree

Marie Detrait

First Name & Middle Initial & Last Name & Degree

Marie-Thérèse Rubio

Facility Name

Hôpital de la Pitié-Salpêtrière

City

Paris

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stéphanie Nguyen, MD

First Name & Middle Initial & Last Name & Degree

Stéphanie Nguyen, MD

First Name & Middle Initial & Last Name & Degree

Laetitia Souchet, MD

First Name & Middle Initial & Last Name & Degree

Madalina Uzunov, MD

Facility Name

CHU de Saint-Etienne

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jérôme Cornillon, MD

First Name & Middle Initial & Last Name & Degree

Jérôme Cornillon, MD

First Name & Middle Initial & Last Name & Degree

Emmanuelle Tavernier, MD

First Name & Middle Initial & Last Name & Degree

Denis Guyotat, MD

First Name & Middle Initial & Last Name & Degree

Caroline Lejeune, MD

First Name & Middle Initial & Last Name & Degree

Fressia Honeyman, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

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