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

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ClinicalTrials.gov Identifier: NCT03439371
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
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, 2020
Estimated Study Completion Date : May 31, 2022


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




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.



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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

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@icloire.fr
Contact: Elisabeth Daguenet, PhD 04 77 91 70 89 ext +33 elisabeth.daguenet@icloire.fr

Locations
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France
CHU Estaing Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Jacques-Olivier Bay, MD         
Principal Investigator: Jacques-Olivier Bay, MD         
Centre Hospitalier Universitaire de Grenoble Not yet recruiting
Grenoble, France
Contact: Claude-Eric Bulabois, MD         
Principal Investigator: Claude-Eric Bulabois         
Sub-Investigator: Martin Carré         
Sub-Investigator: Anne Thiébaut         
Centre Hospitalier Lyon Sud Not yet recruiting
Lyon, France
Contact: Hélène Labussière-Wallet, MD         
Principal Investigator: Hélène Labussière-Wallet         
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         
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Jérôme Cornillon, MD         
Principal Investigator: Jérôme Cornillon, MD         
Sub-Investigator: Emmanuelle Tavernier, MD         
Sub-Investigator: Denis Guyotat, MD         
Sub-Investigator: Caroline Lejeune, MD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Jérôme Cornillon, MD Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03439371     History of Changes
Other Study ID Numbers: 2017-1201
2017-A03572-51 ( Other Identifier: ANSM )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
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 Institut de Cancérologie de la Loire:
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