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.
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
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
Name | Type | Description | Interventions |
---|
HLA-mismatched micro-transplantation | Experimental | HLA-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: | Recruiting |
Lead Sponsor: | Institut de Cancérologie de la Loire |
Trial Keywords
- Acute Myeloid Leukemia
- Micro-transplantation
- Elderly
- Graft-versus-leukemia
Last Updated
July 7, 2020