Clinical Trials /

Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

NCT03439371

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
  • Refractory Anemia with Excess Blasts
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 2017-1201
  • SECONDARY ID: 2017-A03572-51
  • NCT ID: NCT03439371

Conditions

  • Acute Myeloid Leukemia

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
HLA-mismatched micro-transplantationExperimentalHLA-mismatched micro-transplantation

    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
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:60 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of overall survival
    Time Frame:2 years
    Safety Issue:
    Description:Rate of overall survival will be reported.

    Secondary Outcome Measures

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

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:Institut de Cancérologie de la Loire

    Trial Keywords

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

    Last Updated