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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439371
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
Institut de Cancérologie de la Loire
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: HLA-mismatched micro-transplantation after induction chemotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HLA-mismatched micro-transplantation
HLA-mismatched micro-transplantation
 Other: HLA-mismatched micro-transplantation after induction chemotherapy
HLA-mismatched micro-transplantation after induction chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Rate of overall survival [ Time Frame: 2 years ]
    Rate of overall survival will be reported.


Secondary Outcome Measures :
  1. Hematopoietic recovery [ Time Frame: 3 months ]
    Number of platelets will be reported.

  2. Hematopoietic recovery [ Time Frame: 3 months ]
    Number of neutrophils will be reported.

  3. Hematopoietic recovery [ Time Frame: 3 months ]
    Percentage of leukaemic blasts will be reported.

  4. Rate of complete remission [ Time Frame: 2 years ]
    Rate of complete remission :

  5. GVHD (graft versus host disease) [ Time Frame: 2 years ]
    Presence of graft versus host disease will be reported.

  6. Median overall survival [ Time Frame: 2 years ]
    Median overall survival will be calculated.

  7. Median progression-free survival [ Time Frame: 2 years ]
    Median progression-free survival will be calculated.

  8. Microchimerism [ Time Frame: 3 months ]
    Presence of microchimerism will be reported.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439371


Contacts
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Contact: Jérôme Cornillon, MD 04 77 91 67 26 ext +33 jerome.cornillon@chu-st-etienne.fr
Contact: Elisabeth Daguenet, PhD 04 77 91 70 89 ext +33 elisabeth.daguenet@chu-st-etienne.fr

Locations
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France
CHU Estaing Recruiting
Clermont-Ferrand, France, 63000
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         
Centre Hospitalier Universitaire de Grenoble Recruiting
Grenoble, France
Contact: Claude-Eric Bulabois, MD         
Principal Investigator: Claude-Eric Bulabois         
Sub-Investigator: Martin Carré         
Sub-Investigator: Anne Thiébaut         
CHRU de Lille Not yet recruiting
Lille, France
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         
Centre Hospitalier Lyon Sud Recruiting
Lyon, France
Contact: Hélène Labussière-Wallet, MD         
Principal Investigator: 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         
Centre Hospitalier Universitaire de Nancy Not yet recruiting
Nancy, France
Contact: Arnaud Campidelli, MD         
Principal Investigator: Arnaud Campidelli         
Sub-Investigator: Maud D'Aveni         
Sub-Investigator: Marie Detrait         
Sub-Investigator: Marie-Thérèse Rubio         
Hôpital de la Pitié-Salpêtrière Not yet recruiting
Paris, France
Contact: Stéphanie Nguyen, MD         
Principal Investigator: Stéphanie Nguyen, MD         
Sub-Investigator: Laetitia Souchet, MD         
Sub-Investigator: Madalina Uzunov, MD         
CHU de Saint-Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Jérôme Cornillon, MD         
Principal Investigator: Jérôme Cornillon, MD         
Sub-Investigator: Emmanuelle Tavernier, MD         
Sub-Investigator: Denis Guyotat, MD         
Sub-Investigator: Caroline Lejeune, MD         
Sub-Investigator: Fressia Honeyman, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Jérôme Cornillon, MD CHU de Saint-Etienne
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03439371    
Other Study ID Numbers: 2017-1201
2017-A03572-51 ( Other Identifier: ANSM )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Acute Myeloid Leukemia
Micro-transplantation
Elderly
Graft-versus-leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms